Identity
- Trade Name
- ENA CEM HF FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Ena Cem TRY-IN colour BD1/UD1 2g FDA UDI
- Model / Reference
- CPCTUD1 FDA UDI
- Description
- Ena Cem TRY-IN colour BD1/UD1 2g FDA UDI
Identifiers
- Catalog Number
- CPCTUD1 FDA UDI
- Primary DI / UDI-DI
- EMICCPCTUD10 FDA UDI
- 510(k) Number
- K062355 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 — 7 Gram FDA UDI
Category: Dental composite resin
Ena Cem Hf by Micerium Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K062355 also covers:
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
- ENA CEM HF — MICERIUM SPA
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
- Micerium Spa
Sources (1)
- FDA UDI bc4f9649-998a-44c9-a33a-8606e3cbe285 37 fields · synced Jun 8, 2026