OptraGloss

Basic Information

• Brand Name: OptraGloss
• Primary DI: DVIV684548AN1
• Version / Model: 684548AN
• Catalog Number: 684548AN
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Labeler DUNS: 448015938
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 14
• Record Status: Published
• Publish Date: 2020-08-26
• Public Version: 2
• Public Version Date: 2022-03-17
• Public Version Status: Update
• Public Device Record Key: cc596160-7af0-4725-b4fb-36594dbf479f

Device Description

OptraGloss Flame PP, OptraGloss Cup PP, OptraGloss Lens PP, OptraGloss Flame HP, OptraGloss Cup HP, OptraGloss Lens HP, OptraGloss Spiral Wheel HP

Device Characteristics

• Single Use: No
• 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
EHJ	DISK, ABRASIVE	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31833	Dental abrasive point, reusable	A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	DIVO684548AN0	HIBCC
Primary	DVIV684548AN1	HIBCC