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510(k) K100539

PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE by Preventive Technologies, Inc. — Product Code EJR

K100539 is an FDA 510(k) premarket notification submitted by Preventive Technologies, Inc. for the device "PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on June 17, 2010. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030. Preventive Technologies, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2010
Date Received
February 25, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Polishing, Abrasive, Oral Cavity
Device Class
Class I
Regulation Number
872.6030
Review Panel
DE
Submission Type

Other clearances by Preventive Technologies, Inc.

  • K140350 — VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL (December 12, 2014)
  • K951016 — DISPOSABLE PROPHYLAXIS ANGLE (May 2, 1995)

Other clearances for product code EJR

  • K171189 — AIR-FLOW PLUS Prophylaxis powder (September 11, 2017)
  • K131760 — WHIP MIX PREPPIES PLUS (March 26, 2014)
  • K121698 — NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN (August 6, 2012)
  • K103114 — OSSPRAY SYLC CR (March 14, 2011)
  • K102053 — BUTLER CALCI-FLOR PROPHYLAXIS PASTE (February 3, 2011)
  • K101104 — REMIN PRO (October 21, 2010)
  • K070854 — GC MI PASTE PLUS (April 12, 2007)
  • K062502 — OSSPRAY CLEANING COMPOUND (December 15, 2006)
  • K062166 — ENAMEL PRO (November 21, 2006)
  • K042048 — GELATO PROPHYLAXIS PASTE (October 26, 2004)

FDA data resources