FDA.reportPublic FDA data

C-Root

Primary DI
06972902583063
Brand
C-Root
Company
Beijing C-Root Dental Medical Devices Co., LTD.
Model
2g
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.
Published
2023-10-30
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
06972902583063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972902583063069729025830636972902583063

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.

Sterilization Methods#

Method table
Method

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
06972902580024C-Root0.5g*212026-06-10
06972902580062C-Root0.5g2026-06-10
06972902580079C-Root1g2026-06-10
06972902580093C-Root3g2026-06-10
06972902580109C-Root4g2026-06-10
06972902580116C-Root5g2026-06-10
06972902580123C-Root6g2026-06-10
06972902580130C-Root10g2026-06-10
06972902580147C-Root15g2026-06-10
06972902580154C-Root20g2026-06-10
06972902580161C-Root25g2026-06-10
06972902587122C-Root015/02 16mmfile 015/02 16mm2026-06-10
06972902587139C-Root016/02 16mmfile 016/02 16mm2026-06-10
06972902587146C-Root019/02 16mmfile 019/02 16mm2026-06-10
06972902582325C-Root2g*42026-05-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D990ZVSADCK1PK0Single Arch Dam Conversion Kit 1PK, ZimVieSMART DENTURE CONVERSIONS, LLCEIE2026-06-26
06972902580062C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580079C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580093C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580109C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580116C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580123C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580130C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580147C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580154C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
06972902580161C-RootBeijing C-Root Dental Medical Devices Co., LTD.EIE2026-06-10
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10686864060380HEDY DENTAL DAMAMD Medicom IncEIE2024-08-27
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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