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C-Root

Beijing C-Root Dental Medical Devices Co., LTD. · Model 2g · UDI-DI 06972902583063

EIE
10
510(k) clearances
31
Adverse events
1
Recalls
113
Facilities

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.

Recalls

DateFirmReason
2013-12-11Coltene Whaledent IncColtne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packag

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.