FDA UDI
In Commercial Distribution
🇺🇸 United States
C-Root
DI: 06972902583063
·
Model: 2g
·
Beijing C-Root Dental Medical Devices Co., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- C-Root
- Primary DI
- 06972902583063
- Version / Model
- 2g
- Company Name
- Beijing C-Root Dental Medical Devices Co., LTD.
- Labeler DUNS
- 415018580
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-30
- Public Version
- 1
- Public Version Date
- 2023-11-07
- Public Version Status
- New
- Public Device Record Key
- c79141d2-f476-43c3-9255-3f23fd7abb91
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EIE | Dam, Rubber | Dental | 872.6300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45004 | Rubber dam, non-latex | A sheet of elastomeric synthetic material (e.g., silicone) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This device may be used for patients and/or staff that have an allergy to latex. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06972902583063 | GS1 |