Device
C-Root Leak Seal blue is specially designed, cellulose-based caulking and block-out materials that are syringe delivered. It will adhere to a wet rubber dam, gums and oral soft tis...
Manufacturer
Beijing C-Root Dental Medical Devices Co., LTD.
Beijing C-Root Dental Medical Devices Co., LTD.
Model: 2g*4
DI: 06972902582325
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
C-Root Leak Seal blue is specially designed, cellulose-based caulking and block-out materials that are syringe delivered. It will adhere to a wet rubber dam, gums and oral soft tissues, and teeth. It will adhere underwater and saliva.
C-Root Leak Seal blue is a heavier-bodied material with the high adhesive qualities of rubber dam caulking.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1ffbf0cb-153f-4773-bf1d-74f6418f3afc
Distribution Status:
In Commercial Distribution
DUNS Number:
415018580
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
Yes
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06972902582325
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45004
Name: Rubber dam, non-latex
Definition:
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.
FDA Product Codes
EIE
Dam, Rubber