SprintRay Ceramic Crown - A2

GUDID 10850039704434

Intended for the fabrication of individual and fixed definitive full single crowns, definitive partial crowns, individual and fixed single veneers, and artificial teeth for dental prostheses.

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID10850039704434
NIH Device Record Keya8328f42-f7a5-47ed-b580-1d30ba08678e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSprintRay Ceramic Crown - A2
Version Model NumberSRI-0202086
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 Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 Liter
Total Volume0.25 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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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 *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.
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
GS100850039704437 [Primary]
GS110850039704434 [Package]
Contains: 00850039704437
Package: Box [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

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 Date2023-01-25

Devices Manufactured by Sprintray, Inc.

00850070544160 - Ceramic Crown A3 Single-unit Capsule2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed
00850070544177 - Ceramic Crown C2 Single-unit Capsule2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed
00850070544184 - Ceramic Crown D2 Single-unit Capsule2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed
00850070544191 - Ceramic Crown A3 Single-unit Capsule 3-Pack2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed
00850070544207 - Ceramic Crown C2 Single-unit Capsule 3-Pack2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed
00850070544214 - Ceramic Crown D2 Single-unit Capsule 3-Pack2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed
00850070544238 - Ceramic Crown D3 Single-unit Capsule2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed
00850070544252 - Ceramic Crown D3 Single-unit Capsule 3-Pack2025-02-20 SprintRay Ceramic Crown is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed

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