Identity
- Trade Name
- OdneFill FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- OdneFill Endodontic Filler, 10x 0.2 ml, Box of 10 syringes. Hydrophilic, radiopaque, light-curable endodontic sealer, consisting of a liquid, highly flowable material to be applied into the prepared and cleaned root canal and converted into a solid polymer by photocuring. One-material obturation solution that does not require gutta-percha points. FDA UDI
- Model / Reference
- E-0002 FDA UDI
- Description
- OdneFill Endodontic Filler, 10x 0.2 ml, Box of 10 syringes. Hydrophilic, radiopaque, light-curable endodontic sealer, consisting of a liquid, highly flowable material to be applied into the prepared and cleaned root canal and converted into a solid polymer by photocuring. One-material obturation solution that does not require gutta-percha points. FDA UDI
Identifiers
- Catalog Number
- E-0002 FDA UDI
- Primary DI / UDI-DI
- 07649988156618 FDA UDI
- 510(k) Number
- K231387 FDA UDI
- FDA Product Code
- KIF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3820 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental composite resin
OdneFill by Odne AG — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Odne AG
Sources (1)
- FDA UDI d2dd75ae-5cd3-4463-a0cf-a5c3542a2372 37 fields · synced May 30, 2026