Identity
- Trade Name
- CeraRoot Implant System FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- CeraRoot Guided Surgical Tray (empty). It's used to store all the necessary instruments to perform the dental CeraRoot Guided implant surgery. It's made of polymer resistant to dental autoclaves. FDA UDI
- Model / Reference
- 020.002 FDA UDI
- Description
- CeraRoot Guided Surgical Tray (empty). It's used to store all the necessary instruments to perform the dental CeraRoot Guided implant surgery. It's made of polymer resistant to dental autoclaves. FDA UDI
Identifiers
- Catalog Number
- 020.002 FDA UDI
- Primary DI / UDI-DI
- 08435453900737 FDA UDI
- 510(k) Number
- K093595 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
No
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
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
CeraRoot Implant System by Ceraroot Sl. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
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- Implantium, Superline — Dentium Co., Ltd. · Class I
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- Ditron Dental — DITRON DENTAL LTD · Class I
- KLOCKNER — SOADCO, S.L. · Class II
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Osteo KIT — OSSTEM 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ceraroot Sl.
Sources (1)
- FDA UDI 25aece86-9349-4cd8-9f0b-34b2d4233f85 36 fields · synced May 30, 2026