Identity
- Trade Name
- CeraRoot Implant System FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- Implant CeraRoot 12:08/4.1 Size L= 8mm Indicated for UPPER LATERAL INCISORS AND LOWER INCISORS One-piece zirconia dental Implant including abutment. FDA UDI
- Model / Reference
- 120.008 FDA UDI
- Description
- Implant CeraRoot 12:08/4.1 Size L= 8mm Indicated for UPPER LATERAL INCISORS AND LOWER INCISORS One-piece zirconia dental Implant including abutment. FDA UDI
Identifiers
- Catalog Number
- 120.008 FDA UDI
- Primary DI / UDI-DI
- 08435453901222 FDA UDI
- 510(k) Number
- K093595 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Screw endosteal dental implant, one-piece
CeraRoot Implant System by Ceraroot Sl. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, one-piece.
- Infinity External Hex System — ACE SURGICAL SUPPLY CO., INC. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- VERSALIS S PLUS — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- Tryon — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K093595 also covers:
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
- CeraRoot Implant System — CERAROOT SL.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ceraroot Sl.
Sources (1)
- FDA UDI 400eb3cb-c0f5-4a32-b4f4-cad689f2f37e 37 fields · synced May 29, 2026