Ena Bond ®
FDA UDIEUDAMEDClass I (US FDA UDI)
by Micerium Spa
Identity
- Trade Name
- Ena Bond ® FDA UDI
- Generic Name
- Dental material application tool, single-use FDA UDI
- Device Name
- Ena Applicators / Disposable applicator EUDAMEDENA-BOND applicators, medium, blue 1pc FDA UDI
- Model / Reference
- COSM3M-1 EUDAMEDFDA UDIDisposable applicator EUDAMED
- Description
- ENA-BOND applicators, medium, blue 1pc FDA UDI
Identifiers
- Catalog Number
- COSM3M-1 FDA UDI
- Primary DI / UDI-DI
- EMICCOSM3M11 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1D8UG EUDAMED
- FDA Product Code
- EJB FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material application tool, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Total Volume — 5 Milliliter FDA UDI
Category: Dental material application tool, single-use
Ena Bond ® by Micerium Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Micerium Spa
Sources (2)
- FDA UDI 3ce1723f-8b63-4153-b26e-64fbdb3b8b97 36 fields · synced Jun 19, 2026
- EUDAMED 69733418-a135-401e-9c93-4f2edccc019b 61 fields · synced Jun 19, 2026