OptraGloss 684550AN

GUDID DIVO684550AN0

OptraGloss Refill Cup HP

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental abrasive point, reusable

• Primary Device ID: DIVO684550AN0
• NIH Device Record Key: a8bf4c79-5037-4360-8277-05797bf1e62c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptraGloss
• Version Model Number: 684550AN
• Catalog Number: 684550AN
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	DIVO684550AN0 [Unit of Use]
HIBCC	DIVO684550AN1 [Primary]
HIBCC	DVIV684550AN1 [Primary]

FDA Product Code

• EHJ: DISK, ABRASIVE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-03
• Device Publish Date: 2020-08-26

On-Brand Devices [OptraGloss]

• DIVO706172WW1: OptraGloss Flame PP, OptraGloss Kelch PP, OptraGloss Linse PP, OptraGloss Flame HP, OptraGloss K
• DIVO684555AN0: OptraGloss Flame PP, OptraGloss Cup PP, OptraGloss Lens PP, OptraGloss Flame HP, OptraGloss Cup
• DIVO684554AN0: OptraGloss Refill Flame HP
• DIVO684553AN0: OptraGloss Refill Flame PP
• DIVO684552AN0: OptraGloss Refill Lens HP
• DIVO684551AN0: OptraGloss Refill Lens VP
• DIVO684550AN0: OptraGloss Refill Cup HP
• DIVO684549AN0: OptraGloss Refill Cup PP
• DIVO684548AN0: OptraGloss Flame PP, OptraGloss Cup PP, OptraGloss Lens PP, OptraGloss Flame HP, OptraGloss Cup
• DVIV701792WW0: OptraGloss Flame PP, OptraGloss Kelch PP, OptraGloss Linse PP, OptraGloss Flame HP, OptraGloss K
• DIVO742102WW0: OptraGloss Refill Spiral Wheel HP, Instr. for use OptraGloss WW
• DVIV706172WW1: OptraGloss Flame PP, OptraGloss Kelch PP, OptraGloss Linse PP, OptraGloss Flame HP, OptraGloss K