Identity
- Trade Name
- Ena ® FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- ENACEM MIXING TIP 1 pc WITH INTRAORAL NEEDLE FDA UDI
- Model / Reference
- CPCTIPS-1 FDA UDI
- Description
- ENACEM MIXING TIP 1 pc WITH INTRAORAL NEEDLE FDA UDI
Identifiers
- Catalog Number
- CPCTIPS-1 FDA UDI
- Primary DI / UDI-DI
- EMICCPCTIPS10 FDA UDI
- FDA Product Code
- EJB FDA UDI
- GMDN Term
- Dental material injection cannula, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 0.4 Millimeter FDA UDI
Category: Dental material injection cannula, single-use
Ena ® by Micerium Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental material injection cannula, single-use.
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- EDS Mixing Tips — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
- PRIME|ONE — Akzenta International SA · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Micerium Spa
Sources (1)
- FDA UDI d39daa8e-fc7d-4ee4-98c1-398f90a36e37 35 fields · synced May 30, 2026