Identity
- Trade Name
- EVOFILL DUO FDA UDI
- Generic Name
- Endodontic obturation system FDA UDI
- Device Name
- EvoFill Duo(Gutta percha obturation System) is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy. FDA UDI
- Model / Reference
- EVOFILL DUO REGULAR KIT FDA UDI
- Description
- EvoFill Duo(Gutta percha obturation System) is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy. FDA UDI
Identifiers
- Catalog Number
- 4005-1001 FDA UDI
- Primary DI / UDI-DI
- 08806383552332 FDA UDI
- FDA Product Code
- EKR FDA UDI
- GMDN Term
- Endodontic obturation system 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Endodontic obturation system
Evofill Duo by DiaDent Group International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- DiaDent Group International
Sources (1)
- FDA UDI 29bad871-7a1b-4963-8130-04138b15cdaf 35 fields · synced May 30, 2026