OptraGloss 684548AN

GUDID DIVO684548AN0

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

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Dental abrasive point, reusable

• Primary Device ID: DIVO684548AN0
• NIH Device Record Key: cc596160-7af0-4725-b4fb-36594dbf479f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptraGloss
• Version Model Number: 684548AN
• Catalog Number: 684548AN
• Company DUNS: 448015938
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Device Count: 14
• 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	DIVO684548AN0 [Unit of Use]
HIBCC	DIVO684548AN1 [Primary]
HIBCC	DVIV684548AN1 [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