OnX Tough 2 Bleach Single-unit Capsule

GUDID 00850039704925

SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture.

Sprintray, Inc.

Dental appliance fabrication material, resin
Primary Device ID00850039704925
NIH Device Record Keya7219199-49d7-4ef4-bd2e-2939917efb50
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnX Tough 2 Bleach Single-unit Capsule
Version Model NumberSRI-0204061
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 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

Device Dimensions

Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter
Total Volume4 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use OnX Tough 2 after the expiration date
Special Storage Condition, SpecifyBetween 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use OnX Tough 2 after the expiration date
Special Storage Condition, SpecifyBetween 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use OnX Tough 2 after the expiration date
Special Storage Condition, SpecifyBetween 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use OnX Tough 2 after the expiration date
Special Storage Condition, SpecifyBetween 0 and 0 *Store OnX Tough 2 at 15-25oC (60-77oF) and avoid direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Resin must be protected from exposure to light, as spontaneous polymerization is possible.
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use OnX Tough 2 after the expiration date

Device Identifiers

Device Issuing AgencyDevice ID
GS100850039704925 [Primary]

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-17
Device Publish Date2024-12-09

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