Identity
- Trade Name
- Allcem Veneer Try-in FDA UDI
- Generic Name
- Dentifrice FDA UDI
- Device Name
- Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provided when selected the ideal color of Allcem Veneer cement. FDA UDI
- Model / Reference
- E Bleach M 2g FDA UDI
- Description
- Allcem Veneer Try-in accessory is used to simulate the chromatic effect that will be provided when selected the ideal color of Allcem Veneer cement. FDA UDI
Identifiers
- Catalog Number
- 4000055057 FDA UDI
- Primary DI / UDI-DI
- 07899633825783 FDA UDI
- 510(k) Number
- K191389 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dentifrice 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
Yes
FDA UDI
Category: Dentifrice
Allcem Veneer Try-in by Dentscare Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dentifrice.
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Cleared under the same submission
K191389 also covers:
- Allcem Veneer APS — Dentscare Ltda
- Allcem Veneer APS — Dentscare Ltda
- Allcem Veneer APS — Dentscare Ltda
- Allcem Veneer APS — Dentscare Ltda
- Allcem Veneer APS — Dentscare Ltda
- Allcem Veneer APS — Dentscare Ltda
- Allcem Veneer Try-in — Dentscare Ltda
- Allcem Veneer Try-in — Dentscare Ltda
- Allcem Veneer Try-in — Dentscare Ltda
- Allcem Veneer Try-in — Dentscare Ltda
- Allcem Veneer Try-in — Dentscare Ltda
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
- Dentscare Ltda
Sources (1)
- FDA UDI c0aadf52-71fc-4647-9245-32220d303944 35 fields · synced Jun 1, 2026