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510(k) K980995

PLAQ-ATAQ-I by Ethicare — Product Code EFW

K980995 is an FDA 510(k) premarket notification submitted by Ethicare for the device "PLAQ-ATAQ-I". The FDA issued a decision of Substantially Equivalent on August 20, 1998. 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
August 20, 1998
Date Received
February 27, 1998
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)
  • K992435 — BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER (October 15, 1999)
  • K974761 — BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (June 16, 1998)

FDA data resources