SprintRay Apex Teeth - B1 - 500 g

GUDID 00850039704710

APEX Teeth is a light-curable polymerizable resin intended to be used to fabricate artificial teeth for full and partial removable dentures. This material is an alternative to traditional denture teeth material.

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID00850039704710
NIH Device Record Key067b76b8-8bd8-4737-9f46-d2ecbe8e5b9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprintRay Apex Teeth - B1 - 500 g
Version Model NumberSRI-0202159
Company DUNS063005260
Company NameSprintray, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com
Phone800-914-8004
Emailsupport@sprintray.com

Device Dimensions

Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram
Weight500 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including and incompatibilities: Store in a tightly closed container in a cool (29-90°F/-1.7-32.2°C), well-ventilated location away from incompatible materials.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store near high temperatures, light, or ignition sources. Do not store in an oxygen-free environment. Avoid freezing the material

Device Identifiers

Device Issuing AgencyDevice ID
GS100850039704710 [Primary]

FDA Product Code

PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-26
Device Publish Date2024-02-16

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