OnX Tough 2 - Bleach - 3kg

GUDID 00850070544573

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 ID00850070544573
NIH Device Record Keyc918d681-37f6-4bcd-888d-8295624acd26
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnX Tough 2 - Bleach - 3kg
Version Model NumberSRI-0202198
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
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

Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram
Weight3 Kilogram

Device Identifiers

Device Issuing AgencyDevice ID
GS100850070544573 [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 Date2025-03-27
Device Publish Date2025-03-19

Devices Manufactured by Sprintray, Inc.

00850070544412 - APEX Base - Light Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544429 - APEX Base - Original Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544436 - APEX Base - Dark Reddish Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544443 - APEX Base - Opaque Original Pink - 3kg2025-03-27 SprintRay Apex Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and
00850070544450 - OnX Tough 2 - A1 - 3kg2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850070544559 - OnX Tough 2 - A2 - 3kg2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850070544566 - OnX Tough 2 - B1 - 3kg2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp
00850070544573 - OnX Tough 2 - Bleach - 3kg2025-03-27SprintRay 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.
00850070544573 - OnX Tough 2 - Bleach - 3kg2025-03-27 SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supp

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