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510(k) K070127

PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 by Kevin Vu, Dds — Product Code EMN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 29, 2007
Date Received: January 16, 2007
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Scaler, Periodontic
Device Class: Class I
Regulation Number: 872.4565
Review Panel: DE
Submission Type