Ena Cem
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Ena Cem EUDAMEDEnaCem HF FDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- Ena Cem Procedural EUDAMEDENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5 COSM3A-1 ORANGE NEEDLETUBE 20 gauge 5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge 1 CPC-3UD1 ENACEM HF DUAL CEMENT UD1 3g 1 CPC-3UD2 ENACEM HF DUAL CEMENT UD2 3g 1 CPC-3UD3 ENACEM HF DUAL CEMENT UD3 3g 1 CPC-3UD4 ENACEM HF DUAL CEMENT UD4 3g 5 CPCTIPL-1 White Syringe needle 8 CPCTIPN-1 AUTOMIX ENACEM needle 4 CPCTIPS-1 Intraoral Syringe Needle FDA UDI
- Model / Reference
- CPCK EUDAMEDFDA UDICement with bonding EUDAMED
- Description
- ENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5 COSM3A-1 ORANGE NEEDLETUBE 20 gauge 5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge 1 CPC-3UD1 ENACEM HF DUAL CEMENT UD1 3g 1 CPC-3UD2 ENACEM HF DUAL CEMENT UD2 3g 1 CPC-3UD3 ENACEM HF DUAL CEMENT UD3 3g 1 CPC-3UD4 ENACEM HF DUAL CEMENT UD4 3g 5 CPCTIPL-1 White Syringe needle 8 CPCTIPN-1 AUTOMIX ENACEM needle 4 CPCTIPS-1 Intraoral Syringe Needle FDA UDI
Identifiers
- Catalog Number
- CPCK FDA UDI
- Primary DI / UDI-DI
- EMICCPCK1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1ACEMKL8 EUDAMED
- FDA Product Code
- EMA FDA 510(k)FDA UDIDYH FDA UDI
- EMDN Code
- Q01010104 DENTAL BONDING AGENTS EUDAMED
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3275 FDA 510(k)
- Regulation Number
- 872.3275 FDA 510(k)FDA UDI872.3750 FDA UDI
- Advisory Committee
- Dental FDA 510(k)
- Medical Purpose
- Luting composite,for cementation of posts and core build-ups, for luting of ceramic and composite inlays, onlays veneers and crowns. EUDAMED
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Ena Cem is a dental cement classified as a Dental Cement (OpenFDA: K062355), designed for restorative applications in dentistry. It is formulated as a hybrid restorative composite, combining properties of both cement and composite materials to provide durable and aesthetic dental restorations.
This device is supplied as a dual-cure system, intended for use in clinical settings by dental professionals. It is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance and MDR authorization. The product is non-sterile and supplied in multiple reference codes for various dental applications, with specific attention to compatibility with composite bases and restorative techniques.
Frequently asked questions
What types of dental restorations is Ena Cem specifically designed for, and how does its dual-cure system benefit the clinician?
Ena Cem is a hybrid restorative composite dental cement designed for restorative applications in dentistry, particularly where durability and aesthetics are critical. Its dual-cure system allows for polymerization through both light activation (for areas accessible to a curing lamp) and chemical reaction (for deeper or less accessible areas), ensuring complete setting and stronger adhesion to composite bases. This versatility makes it suitable for inlays, onlays, and other indirect restorations where precise bonding and long-term stability are required.
Is Ena Cem pre-sterilized, and if not, what precautions should be taken before clinical use?
Ena Cem is supplied in a non-sterile form, meaning it must be sterilized or prepared under aseptic conditions before clinical use. Since it is intended for direct application in dental procedures, it should be handled in a clean environment, and any packaging should be opened only with sterile instruments. If the kit includes multiple components (e.g., powder and liquid), ensure both are sterilized or used in a manner compliant with dental infection control protocols.
How many reference codes or variants of Ena Cem are available, and what does this indicate about its versatility?
Ena Cem is available in multiple reference codes (over 100 listed in the data), each corresponding to specific formulations or packaging sizes tailored for various dental applications. This extensive range suggests compatibility with different restorative techniques, composite bases, and clinical scenarios—such as anterior or posterior restorations—allowing practitioners to select the most suitable variant for their patient’s needs.
What regulatory pathways has Ena Cem undergone, and how does this affect its availability in different markets?
Ena Cem has received FDA 510K clearance (under the Traditional pathway) and MDR authorization, confirming its compliance with U.S. and EU regulatory standards. This dual approval allows the device to be legally marketed in both the U.S. and European Economic Area (EEA) markets, though clinicians should verify local distribution channels and any additional country-specific requirements before procurement.
Does Ena Cem require special storage conditions, and if so, what are the key considerations for maintaining its integrity?
While the data does not specify exact storage conditions, as a dental cement, Ena Cem should ideally be stored in a cool, dry place (typically 15–25°C) away from direct sunlight or moisture to prevent degradation of its chemical properties. If the product includes sealed components (e.g., capsules or vials), ensure packaging remains intact until use to preserve sterility and performance. Always follow the manufacturer’s instructions for the specific variant in use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ena Cem HF Traditional hybrid restorative composite - Micerium S.p.A, Ena Post & Ena Cem Dual cement with composite base - Micerium S.p.A, Ena Cem HV Composite for veneer cementation - Micerium S.p.A
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K062355 | Class II | Active |
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Manufacturer
- Manufacturer
- Micerium S.p.A.
Sources (3)
- FDA 510(k) K062355 24 fields · synced Sep 18, 2026
- FDA UDI 2c0e575a-2d55-4f05-8539-122fff2f2338 36 fields · synced May 30, 2026
- EUDAMED 81438979-ac04-48b6-93a7-90688f18e89b 61 fields · synced Sep 17, 2026