Identity
- Trade Name
- EnaCem Z FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Name: ENA CEM Model: Z Kit EUDAMEDENACEM Z KIT PRIMER + CEMENT 1 CPCZ ENACEM Z zirconia cement 8g. 1 CPCZP ENACEM Z Primer 5 ml. FDA UDI
- Model / Reference
- CPCZK EUDAMEDFDA UDI
- Description
- ENACEM Z KIT PRIMER + CEMENT 1 CPCZ ENACEM Z zirconia cement 8g. 1 CPCZP ENACEM Z Primer 5 ml. FDA UDI
Identifiers
- Catalog Number
- CPCZK FDA UDI
- Primary DI / UDI-DI
- EMICCPCZK1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1ACEMZK4N EUDAMED
- 510(k) Number
- K062355 FDA UDI
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 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
No
FDA UDI
Combination Product
Yes
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 — 8 Gram FDA UDITotal Volume — 5 Milliliter FDA UDI
Category: Glass ionomer dental cement
EnaCem Z by Micerium Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Glass ionomer dental cement.
- 3M™ Ketac™ Fil Plus Aplicap™ — 3M Deutschland GmbH · Class II
- KETAC™ — 3M COMPANY · Class II
- Ketac™ Cem radiopaque — 3M Deutschland GmbH · Class II
- Vitremer™ — 3M COMPANY · Class II
- SciPharm Until Temporary Crown and Bridge Cement — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
- Precedent — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Vivid Glass Restorative A2 Std Pkg — PEARSON DENTAL SUPPLIES, INC. · Class II
- GC Fuji II LC® — Gc America Inc. · 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 514f8168-252a-4637-892d-8ed6a97998f7 37 fields · synced Jul 9, 2026
- EUDAMED 9a65ce2c-57d6-47d7-997a-dbac0dd4df1d 61 fields · synced Jul 9, 2026