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510(k) K140350

VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL by Preventive Technologies, Inc. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2014
Date Received
February 11, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

Other clearances by Preventive Technologies, Inc.

  • K100539 — PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (June 17, 2010)
  • K951016 — DISPOSABLE PROPHYLAXIS ANGLE (May 2, 1995)

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