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510(k) K033449

PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES by Professional Dental Technologies Therapeutics, Inc. — Product Code EJR

K033449 is an FDA 510(k) premarket notification submitted by Professional Dental Technologies Therapeutics, Inc. for the device "PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES". The FDA issued a decision of Substantially Equivalent on January 7, 2004. The device falls under product code EJR (Agent, Polishing, Abrasive, Oral Cavity), a Class I device regulated under 21 CFR 872.6030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2004
Date Received
October 29, 2003
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 for product code EJR

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  • 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)
  • K100539 — PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE (June 17, 2010)
  • K070854 — GC MI PASTE PLUS (April 12, 2007)
  • K062502 — OSSPRAY CLEANING COMPOUND (December 15, 2006)
  • K062166 — ENAMEL PRO (November 21, 2006)

FDA data resources