Identity
- Trade Name
- OptiDisc FDA UDI
- Generic Name
- Dental abrasive disk, reusable FDA UDI
- Device Name
- Finishing and Polishing Discs - Extra-Coarse - Refill - For Use with Low-Speed Handpiece FDA UDI
- Model / Reference
- 33483 FDA UDI
- Description
- Finishing and Polishing Discs - Extra-Coarse - Refill - For Use with Low-Speed Handpiece FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841396117968 FDA UDI
- FDA Product Code
- EHJ FDA UDI
- GMDN Term
- Dental abrasive disk, 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 12.6 Millimeter FDA UDI
Category: Dental abrasive disk, reusable
OptiDisc by Kerr Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive disk, reusable.
- EDENTA — EDENTA ETABLISSEMENT · Class I
- HORICO — Hopf, Ringleb & Co. GmbH & Cie. · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Defend — Young Innovations, Inc. · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- EDENTA — EDENTA ETABLISSEMENT · Class I
- Salvin Dental Specialties — SALVIN DENTAL SPECIALTIES, LLC · 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
- Kerr Corporation
Sources (1)
- FDA UDI 9b1f076a-2281-4a59-b718-d64c54f93279 36 fields · synced Jun 8, 2026