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510(k) K152322

Resolve 2.0 by Denali Corporation — Product Code PME

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 16, 2015
Date Received: August 17, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: External Cleaning Solution
Device Class: Class II
Regulation Number: 872.3260
Review Panel: DE
Submission Type

For use on dental restorations, external to the mouth, prior to insertion into the mouth.

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