SprintRay High Impact Denture Base - Dark Pink

GUDID 10850039704403

SprintRay High Impact Denture Base is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates.

Sprintray, Inc.

Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin
Primary Device ID10850039704403
NIH Device Record Key8196807a-6361-4314-8432-74fc8dc586dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprintRay High Impact Denture Base - Dark Pink
Version Model NumberSRI-0202099
Company DUNS063005260
Company NameSprintray, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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

Device Dimensions

Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter
Total Volume1 Liter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.
Special Storage Condition, SpecifyBetween 0 and 0 *Conditions for safe storage, including any 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. Do not sto
Special Storage Condition, SpecifyBetween 0 and 0 *Do not store in an oxygen-free environment. Avoid freezing the material.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850039704406 [Primary]
GS110850039704403 [Package]
Contains: 00850039704406
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-29
Device Publish Date2023-01-23

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