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510(k) K192961

ADH19 by 3M Deutschland GmbH — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2019
Date Received
October 22, 2019
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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