Identity
- Trade Name
- Renamel® Microhybrid FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Model / Reference
- 6061C3 FDA UDI
Identifiers
- Catalog Number
- 6061C3 FDA UDI
- Primary DI / UDI-DI
- D7796061C30 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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: Dental composite resin
Renamel® Microhybrid by Cosmedent, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K222435 also covers:
- Renamel® Flowable Microhybrid — Cosmedent, Inc.
- Renamel® Flowable Microhybrid — Cosmedent, Inc.
- Renamel® Flowable Microhybrid — Cosmedent, Inc.
- Renamel® Flowable Microhybrid — Cosmedent, Inc.
- Renamel® Flowable Microhybrid — Cosmedent, Inc.
- Renamel® Flowable Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
K921820 also covers:
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
- Renamel® Microhybrid — Cosmedent, Inc.
Manufacturer's product page: Renamel Microhybrid Composite
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cosmedent, Inc.
Sources (1)
- FDA UDI a0c8fb7b-994c-432f-83bd-8710ff7b1fe2 34 fields · synced May 30, 2026