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510(k) K242934

Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) by Longly Biotechnology (Wuhan) Co., Ltd. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2024
Date Received
September 25, 2024
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 Longly Biotechnology (Wuhan) Co., Ltd.

  • K241977 — Injectable Root Canal Bioceramic Sealer (i-MTA SP) (October 3, 2024)

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