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CeraRoot® Transporter 12 - ceramic
EUDAMEDFDA UDIClass I (EU MDR)
Ref 006.012
by CeraRoot SL
Identity
- Trade Name
- CeraRoot® Transporter 12 - ceramic EUDAMEDCeraRoot Implant System FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- CeraRoot® Ceramic Transporter EUDAMEDTransporter 12 - ceramic for the CeraRoot 12 implant FDA UDI
- Model / Reference
- 006.012 EUDAMEDFDA UDI
- Description
- Transporter 12 - ceramic for the CeraRoot 12 implant FDA UDI
Identifiers
- Catalog Number
- 006.012 FDA UDI
- Primary DI / UDI-DI
- 08435453900553 EUDAMEDFDA UDI
- Basic UDI-DI
- 84354539CTEG EUDAMED
- 510(k) Number
- K093595 FDA UDI
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Outer Diameter — 4.1 Millimeter FDA UDI
CeraRoot® Transporter 12 - ceramic by Ceraroot Sl. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 84354539CTEG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- CeraRoot SL
- EUDAMED SRN
- ES-MF-000000251
Sources (2)
- EUDAMED db4e177d-7650-4d79-9a50-86e783437f4b 61 fields · synced Jun 19, 2026
- FDA UDI 277e8bcb-025d-41f0-b132-828ccfa2db6b 37 fields · synced May 30, 2026