Identity
- Trade Name
- Porcelize FDA UDI
- Generic Name
- Professional dental abrasive material FDA UDI
- Model / Reference
- 906104 FDA UDI
Identifiers
- Catalog Number
- 906104 FDA UDI
- Primary DI / UDI-DI
- D7799061040 FDA UDI
- 510(k) Number
- K854588 FDA UDI
- FDA Product Code
- EJR FDA UDI
- GMDN Term
- Professional dental abrasive material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6030 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Professional dental abrasive material
Porcelize by Cosmedent, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K854588 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cosmedent, Inc.
Sources (1)
- FDA UDI d4f0ac73-feb6-4d5f-b9ac-d89736400fef 34 fields · synced May 30, 2026