Identity
- Trade Name
- C-Root FDA UDI
- Generic Name
- Rubber dam, non-latex FDA UDI
- Device Name
- C-Root Caulking Putty Paste is specially designed, cellulose-based caulking and block-out materials that are syringe delivered. It will adhere to a wet rubber dam, gingival and mucosal tissues, and teeth. It will adhere under water and saliva. C-Root Caulking Putty Paste is a heavier -bodied material with the high adhesive qualities of rubber dam caulking. FDA UDI
- Model / Reference
- 2g FDA UDI
- Description
- C-Root Caulking Putty Paste is specially designed, cellulose-based caulking and block-out materials that are syringe delivered. It will adhere to a wet rubber dam, gingival and mucosal tissues, and teeth. It will adhere under water and saliva. C-Root Caulking Putty Paste is a heavier -bodied material with the high adhesive qualities of rubber dam caulking. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972902583063 FDA UDI
- FDA Product Code
- EIE FDA UDI
- GMDN Term
- Rubber dam, non-latex FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6300 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rubber dam, non-latex
C-Root by Beijing C-Root Dental Medical Devices Co., LTD. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Beijing C-Root Dental Medical Devices Co., LTD.
Sources (1)
- FDA UDI c79141d2-f476-43c3-9255-3f23fd7abb91 33 fields · synced May 30, 2026