Identity
- Trade Name
- C-Root EDTA Gel EUDAMEDC-Root FDA UDI
- Generic Name
- Dental root surface conditioner FDA UDI
- Device Name
- C-Root EDTA Gel EUDAMED
- Model / Reference
- EDTA 6g EUDAMED6g FDA UDI
Identifiers
- Catalog Number
- 1 FDA UDI
- Primary DI / UDI-DI
- 06972902582288 EUDAMEDFDA UDI
- Basic UDI-DI
- 69729025802XC EUDAMED
- FDA Product Code
- EKQ FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental root surface conditioner FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Dental appliance fabrication material, ceramic
C-Root EDTA Gel by Beijing C-Root Dental Medical Devices Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, ceramic.
- Razor / MegaPlus — U&C International Co., Ltd · Class II
- rainbow High shine — Genoss · Class II
- Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
- CGI — CERAGROUP INDUSTRIES · Class II
- ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69729025802XC | Class I | Active |
| 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
- Beijing C-Root Dental Medical Devices Co., LTD.
- EUDAMED SRN
- CN-MF-000033502
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 5244d267-a4ce-41b4-8f44-9dd5289f45f7 61 fields · synced Jul 8, 2026
- FDA UDI 9476645d-3c31-46bd-b811-fdc8a0ad21fc 33 fields · synced May 30, 2026