Ena ®
FDA UDIEUDAMEDClass I (US FDA UDI)
by Micerium Spa
Identity
- Trade Name
- Ena ® FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- Ena Applicators / Disposable applicator EUDAMEDEna Cem automix brown tips 50 pcs short FDA UDI
- Model / Reference
- CPCTIPNX EUDAMEDFDA UDIDisposable applicator EUDAMED
- Description
- Ena Cem automix brown tips 50 pcs short FDA UDI
Identifiers
- Catalog Number
- CPCTIPNX FDA UDI
- Primary DI / UDI-DI
- EMICCPCTIPNX1 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 injection cannula, 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
Yes
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
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.4 Millimeter FDA UDI
Category: Dental material injection cannula, single-use
Ena ® by Micerium Spa — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental material injection cannula, single-use.
- Clinician's Choice® Needle Tubes & Plugs — Den-Mat Holdings, LLC · Class I
- PRIME|ONE — Akzenta International SA · Class I
- NaviTip Tips — ULTRADENT PRODUCTS, INC. · Class I
- CanalPro™ Color Syringes — Coltène/Whaledent AG · Class I
- RelyX™ Unicem 2 Automix — 3M Deutschland GmbH · Class I
- Avalon Biomed NeoSEALER 20 Flex Flo Tips — NUSMILE, LTD · Class I
- EDS Mixing Tips — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
- PRIME|ONE — Akzenta International SA · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micerium Spa
Sources (2)
- FDA UDI 34456a01-8cf6-4922-ae03-8b33e2465513 35 fields · synced Jun 18, 2026
- EUDAMED c309edcb-a581-4d65-b3b1-8ce6b02d04d8 61 fields · synced Jun 18, 2026