Identity
- Trade Name
- BRILLIANT Crios FDA UDI
- Generic Name
- Resin dental inlay FDA UDI
- Device Name
- BRILLIANT Crios CEREC/inLab – 5 blocs Size 14, Low Translucent, B2 BRILLIANT Crios is a reinforced composite bloc for the fabrication of permanent, aesthetic single-tooth restorations using a CAD/CAM milling process. BRILLIANT Crios is available in a variety of shades and sizes. Composition: Dental glass, cross-linked methacrylates, amorphous silica. FDA UDI
- Model / Reference
- 60019991 FDA UDI
- Description
- BRILLIANT Crios CEREC/inLab – 5 blocs Size 14, Low Translucent, B2 BRILLIANT Crios is a reinforced composite bloc for the fabrication of permanent, aesthetic single-tooth restorations using a CAD/CAM milling process. BRILLIANT Crios is available in a variety of shades and sizes. Composition: Dental glass, cross-linked methacrylates, amorphous silica. FDA UDI
Identifiers
- Catalog Number
- 60019991 FDA UDI
- Primary DI / UDI-DI
- J00660019991 FDA UDI
- 510(k) Number
- K181500 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Resin dental inlay 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: Resin dental inlay
BRILLIANT Crios by Coltène/Whaledent AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181500 also covers:
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
- BRILLIANT Crios — Coltène/Whaledent AG
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
- Coltène/Whaledent AG
Sources (1)
- FDA UDI b15848f8-dbc0-4b78-9163-99bee44862cf 37 fields · synced May 30, 2026