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Ena Matrix
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref EMWWModel Wooden wedges
by Micerium Spa
Identity
- Trade Name
- Ena Matrix FDA UDI
- Generic Name
- Dental wedge, single-use FDA UDI
- Device Name
- Ena Matrix Wood / Wooden wedges EUDAMEDEna Matrix Wooden wedges: 100 pcs Extra Small (orange); 100 pcs Small (white); 100 pcs Medium (yellow) 100 pcs Large (pink) FDA UDI
- Model / Reference
- EMWW EUDAMEDFDA UDIWooden wedges EUDAMED
- Description
- Ena Matrix Wooden wedges: 100 pcs Extra Small (orange); 100 pcs Small (white); 100 pcs Medium (yellow) 100 pcs Large (pink) FDA UDI
Identifiers
- Catalog Number
- EMWW FDA UDI
- Primary DI / UDI-DI
- EMICEMWW1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++EMICFAM1HWO4B EUDAMED
- FDA Product Code
- EJB FDA UDI
- EMDN Code
- Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY EUDAMED
- GMDN Term
- Dental wedge, 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
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
Yes
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
Category: Dental wedge, single-use
Ena Matrix 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
European Union Unknown
MDR
United States Pending data
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 69782429-8f87-4e5c-b49f-519649dfe8aa 34 fields · synced Jul 17, 2026
- EUDAMED 7ffdfbb7-3132-432e-9b33-6bffaf13ae79 61 fields · synced Jul 17, 2026