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510(k) K781018

DX TOOTHBRUSH by Lever Brothers Company, Inc. — Product Code EFW

K781018 is an FDA 510(k) premarket notification submitted by Lever Brothers Company, Inc. for the device "DX TOOTHBRUSH". The FDA issued a decision of Substantially Equivalent on June 30, 1978. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855. Lever Brothers Company, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1978
Date Received
June 16, 1978
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 Lever Brothers Company, Inc.

  • K850610 — PEPSODENT DENTURE ADHESIVE CREAM (May 15, 1985)
  • K851183 — PEPSODENT DENTURE CLEANSER PDP FORMULA (April 29, 1985)
  • K851182 — PEPSODENT DENTURE CLEANSER-WESTONE FORMULA (April 29, 1985)

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)
  • K980995 — PLAQ-ATAQ-I (August 20, 1998)

FDA data resources