Home / 510(k) Clearances / K231696

510(k) K231696

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal by Prevest Denpro Limited — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2023
Date Received
June 12, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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