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510(k) K971002

SMILE WITH CONFIDENCE by Lloyd V. Ziemendorf — Product Code EHS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 15, 1997
Date Received: March 19, 1997
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Cushion, Denture, Over The Counter
Device Class: Class II
Regulation Number: 872.3540
Review Panel: DE
Submission Type