Identity
- Trade Name
- ENA CEM HF FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Name: ENA CEM Model: LOW VISCOSITY EUDAMEDDUAL CEMENT ENACEM FDA UDI
- Model / Reference
- CPC EUDAMEDFDA UDI
- Description
- DUAL CEMENT ENACEM FDA UDI
Identifiers
- Catalog Number
- CPC FDA UDI
- Primary DI / UDI-DI
- EMICCPC1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1ACEM7A EUDAMED
- 510(k) Number
- K062355 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 9c226d35-b67a-47a9-9387-281111967011 37 fields · synced Jul 14, 2026
- EUDAMED df7794f2-4069-4294-9cb2-4497929d16e1 61 fields · synced Jul 14, 2026