Identity
- Trade Name
- CeraRoot Implant System FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Countersink 14 - for the implants CeraRoot 14 and the CeraRoot 34 and 34L- orange and violet color coded - steel FDA UDI
- Model / Reference
- 003.014 FDA UDI
- Description
- Countersink 14 - for the implants CeraRoot 14 and the CeraRoot 34 and 34L- orange and violet color coded - steel FDA UDI
Identifiers
- Catalog Number
- 003.014 FDA UDI
- Primary DI / UDI-DI
- 08435453900393 FDA UDI
- 510(k) Number
- K093595 FDA UDI
- FDA Product Code
- DZI FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8 Millimeter FDA UDI
Category: Fixture/appliance dental drill bit, reusable
CeraRoot Implant System by Ceraroot Sl. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
- Bone Compaction Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Prima Plus — Keystone Dental Inc. · Class I
- FTN Tapered Drill — DIO Corporation · Class I
- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
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 01eb7779-8b4c-4cd6-8caa-41428da73269 37 fields · synced May 31, 2026