FDA.reportPublic FDA data

C-Root

Primary DI
06972902582325
Brand
C-Root
Company
Beijing C-Root Dental Medical Devices Co., LTD.
Model
2g*4
Device 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.
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIEDam, Rubber

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIEDam, RubberDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972902582325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972902582325069729025823256972902582325

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam, non-latexA 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.

Regulatory Flags#

DUNS number
415018580
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972902583292C-Root1g2026-05-15
06972902583308C-Root0.5g2026-05-15
06972902588129C-Root 020/08 19mm file 020/08 19mm2026-05-15
06972902588136C-Root 025/08 19mm file 025/08 19mm2026-05-15
06972902588143C-Root 015/09 19mm file 015/09 19mm2026-05-15
06972902588150C-Root 020/09 19mm file 020/09 19mm2026-05-15
06972902588167C-Root030/09 19mm file 030/09 19mm2026-05-15
06972902588174C-Root 015/10 19mm file 015/10 19mm2026-05-15
06972902588181C-Root020/10 19mm file 020/10 19mm2026-05-15
06972902588204C-Root 015/02 21mm file 015/02 21mm2026-05-15
06972902588211C-Root 016/02 21mm file 016/02 21mm2026-05-15
06972902588228C-Root019/02 21mm file 019/02 21mm2026-05-15
06972902588112C-Root 015/08 19mm file 015/08 19mm2025-06-08
06972902580086C-Root100ml100ml2025-05-22
06972902583537C-Root12025-01-23
06972902581663C-Root0.5g12024-05-17
06972902583711C-Root1g12024-05-17
06972902583728C-Root2g12024-05-17
06972902582288C-Root6g12024-05-16
06972902581861C-Root0.5g12023-11-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840161302694Insti-Dam® - Latex-Free Rubber Dam - 20 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
00840161302717Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 20 CountZIRC DENTAL PRODUCTS, INC.EIE2026-04-07
07630392912129HySolateDent4You AGEIE2025-12-18
07630392912136HySolateDent4You AGEIE2025-12-18
10686864060298HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060304HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060311HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060328HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060335HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060342HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060359HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060366HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060373HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060380HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060397HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060403HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060410HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060427HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060434HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
10686864060441HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
07630392910781HySolateDent4You AGEIE2024-07-11
07630392910972HySolateDent4You AGEIE2024-07-11
00630094043265Bioseal Inc.BIOSEALEIE2024-01-18
10732224005581Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005598Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005604Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005611Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005628Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005635Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20
10732224005642Dental DamsCROSSTEX INTERNATIONAL, INC.EIE2023-12-20