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510(k) K992435

BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER by Azo Enterprises — Product Code EFW

K992435 is an FDA 510(k) premarket notification submitted by Azo Enterprises for the device "BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER". The FDA issued a decision of Substantially Equivalent on October 15, 1999. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1999
Date Received
July 22, 1999
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 for product code EFW

  • K130186 — DENTEK EASY BRUSH WITH FLUORIDE (July 15, 2013)
  • 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)
  • K980995 — PLAQ-ATAQ-I (August 20, 1998)
  • K974761 — BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (June 16, 1998)

FDA data resources