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510(k) K130186

DENTEK EASY BRUSH WITH FLUORIDE by Den Tek Oral Care, Inc. — Product Code EFW

K130186 is an FDA 510(k) premarket notification submitted by Den Tek Oral Care, Inc. for the device "DENTEK EASY BRUSH WITH FLUORIDE". The FDA issued a decision of Substantially Equivalent on July 15, 2013. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855. Den Tek Oral Care, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2013
Date Received
January 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Toothbrush, Manual
Device Class
Class I
Regulation Number
872.6855
Review Panel
DE
Submission Type

Other clearances by Den Tek Oral Care, Inc.

  • K151149 — Ready-Fit (September 30, 2015)
  • K123849 — NEW COMFORT-FIT DENTAL GUARD (January 10, 2013)
  • K091660 — CUSTOM COMFORT NIGHTGUARD VERSION 2 (June 12, 2009)
  • K083400 — CUSTOM COMFORT NIGHTGUARD (December 11, 2008)
  • K081669 — IMPROVED COMFORT-FIT NIGHTGUARD (July 10, 2008)
  • K072147 — DEN TEK COMFORT FIT NIGHTGUARD (August 30, 2007)
  • K063483 — DEN TEK NIGHTGUARD (January 23, 2007)

Other clearances for product code EFW

  • K121165 — BEAM BRUSH/BEAM APP (June 21, 2012)
  • K102871 — SILVER CARE ANITBACTERIAL TOOTHBRUSH (October 3, 2011)
  • K073224 — ORAL-B SUB-BRAND MANUAL TOOTHBRUSH (February 6, 2008)
  • K021383 — ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL (July 17, 2002)
  • K020776 — MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS (June 3, 2002)
  • K000290 — LAZERSMILE, LAZERWHITE (April 14, 2000)
  • K994144 — TOOTHBRUSH WASH (March 2, 2000)
  • K992435 — BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER (October 15, 1999)
  • K980995 — PLAQ-ATAQ-I (August 20, 1998)
  • K974761 — BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (June 16, 1998)

FDA data resources