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510(k) K232978

DX. Bond V Dental Bonding Adhesive by Sino-Dentex Co., Ltd. — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2023
Date Received
September 21, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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