Identity
- Trade Name
- Nuance® FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- NUANCE A1 UNIV COMPULE FDA UDI
- Model / Reference
- CR1135 FDA UDI
- Description
- NUANCE A1 UNIV COMPULE FDA UDI
Identifiers
- Catalog Number
- CR1135 FDA UDI
- Primary DI / UDI-DI
- D813CR11350 FDA UDI
- 510(k) Number
- K101215 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
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
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
Nuance® by Den-Mat Holdings, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K101215 also covers:
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
- Nuance® — Den-Mat Holdings, LLC
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
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 4f4b31a6-a2e0-4363-b917-80e12fd65b14 37 fields · synced Jun 9, 2026