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510(k) K220804

Dia-X Bond Universal by DiaDent Group International — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2022
Date Received
March 18, 2022
Clearance Type
Special
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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