OnX Tough - Hollywood Bleach

Basic Information

• Brand Name: OnX Tough - Hollywood Bleach
• Primary DI: 00850039704178
• Version / Model: SRI-0202071
• Catalog Number: SRI-0202071
• Company Name: Sprintray, Inc.
• Labeler DUNS: 063005260
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-04
• Public Version: 2
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: 9a44234f-3140-489f-85b5-8bb042c92434

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	872.3590	2
ELM	Denture, Plastic, Teeth	Dental	872.3590	2
ELK	Teeth, Artificial, Backing And Facing	Dental	872.3910	1
ELJ	Teeth, Artificial, Posterior With Metal Insert	Dental	872.3900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16730	Dental appliance fabrication material, resin	A resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850039704175	GS1	Box	1	In Commercial Distribution
Primary	00850039704178	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Total Volume	1	Liter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 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