Identity
- Trade Name
- Amaris FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Highly aesthetic light-curing restorrative material. Two simple steps, perfect result. Layering like in nature: shades are created from the inside of the tooth. Simple and precise shade match. Natural shade transitions automatically. Long resistance to ambient and chair light. Natural fluorescence and high colour stability. FDA UDI
- Model / Reference
- 1936 FDA UDI
- Description
- Highly aesthetic light-curing restorrative material. Two simple steps, perfect result. Layering like in nature: shades are created from the inside of the tooth. Simple and precise shade match. Natural shade transitions automatically. Long resistance to ambient and chair light. Natural fluorescence and high colour stability. FDA UDI
Identifiers
- Catalog Number
- 1936 FDA UDI
- Primary DI / UDI-DI
- E22119361 FDA UDI
- 510(k) Number
- K071386 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
Amaris by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (1)
- FDA UDI de5df18a-ec53-4d90-ad82-ed0ec8f1cea6 37 fields · synced Jun 1, 2026