SprintRay NightGuard Firm SRI-0202016

GUDID 10850039704168

The material is an alternative to traditional dental prostheses material. SprintRay NightGuard Firm resin is intended exclusively for professional dental work.

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID10850039704168
NIH Device Record Keyf45e75cb-96b2-429c-910c-847c39ff5b9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprintRay NightGuard Firm
Version Model NumberSRI-0202016
Catalog NumberSRI-0202016
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 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
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
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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 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s
Special Storage Condition, SpecifyBetween 0 and 0 *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 store near high temperatures, light or ignition sources. Do not s

Device Identifiers

Device Issuing AgencyDevice ID
GS100850039704161 [Primary]
GS110850039704168 [Package]
Contains: 00850039704161
Package: Box [1 Units]
In Commercial Distribution

FDA Product Code

DYTMaintainer, Space Preformed, Orthodontic
KMYPositioner, Tooth, Preformed

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 Date2022-11-01

Devices Manufactured by Sprintray, Inc.

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