Identity
- Trade Name
- Nacera FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Translucent liquid. Increases translucency in the incisal area where applied. Only allowed to be used with products of Nacera® Pearl (3Y-TZP). FDA UDI
- Model / Reference
- Blue X FDA UDI
- Description
- Translucent liquid. Increases translucency in the incisal area where applied. Only allowed to be used with products of Nacera® Pearl (3Y-TZP). FDA UDI
Identifiers
- Catalog Number
- 4000LQ8030 FDA UDI
- Primary DI / UDI-DI
- EDMC4000LQ80300 FDA UDI
- 510(k) Number
- K092020 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 15 Gram FDA UDI
Nacera by Doceram Medical Ceramics GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Doceram Medical Ceramics GmbH
Sources (1)
- FDA UDI 004c561a-1207-4ce4-bde7-a747e57a4b8e 39 fields · synced Jun 1, 2026