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510(k) K212983

Injectable Root Canal Bioceramic Sealer by Beijing C-Root Dental Medical Devices Co., Ltd. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2021
Date Received
September 17, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type

Other clearances by Beijing C-Root Dental Medical Devices Co., Ltd.

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