Identity
- Trade Name
- OptraGloss FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- OptraGloss Flame PP, OptraGloss Cup PP, OptraGloss Lens PP, OptraGloss Flame HP, OptraGloss Cup HP, OptraGloss Lens HP, OptraGloss Spiral Wheel HP FDA UDI
- Model / Reference
- 684548AN FDA UDI
- Description
- OptraGloss Flame PP, OptraGloss Cup PP, OptraGloss Lens PP, OptraGloss Flame HP, OptraGloss Cup HP, OptraGloss Lens HP, OptraGloss Spiral Wheel HP FDA UDI
Identifiers
- Catalog Number
- 684548AN FDA UDI
- Primary DI / UDI-DI
- DVIV684548AN1 FDA UDI
- FDA Product Code
- EHJ FDA UDI
- GMDN Term
- Dental abrasive point, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental abrasive point, reusable
OptraGloss by Ivoclar Vivadent Aktiengesellschaft — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive point, reusable.
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- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Alpen — Coltene/Whaledent Inc. · Class I
- Strauss Diamond — Diamond Strauss Instruments Inc · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ivoclar Vivadent Aktiengesellschaft
Sources (1)
- FDA UDI cc596160-7af0-4725-b4fb-36594dbf479f 34 fields · synced Jun 8, 2026