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510(k) K971589

REACH ANTIBACTERIAL TOOTHBRUSH by Personal Products Co. — Product Code EFW

K971589 is an FDA 510(k) premarket notification submitted by Personal Products Co. for the device "REACH ANTIBACTERIAL TOOTHBRUSH". The FDA issued a decision of Substantially Equivalent on July 24, 1997. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855. Personal Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1997
Date Received
May 1, 1997
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 Personal Products Co.

  • K070545 — K-Y BRAND WARMING LIQUID (March 23, 2007)
  • K062796 — K-Y BRAND INTRIGUE (December 8, 2006)
  • K010365 — ORTHO CONTROL FEMALE URINARY CONTROL DEVICE (April 30, 2001)
  • K990536 — O.B. TAMPON (August 31, 1999)
  • K991118 — O.B. APPLICATOR TAMPONS, O.B. TAMPONS (June 29, 1999)
  • K974629 — O.B. APPLICATOR AND NON-APPLICATOR TAMPONS (February 10, 1998)
  • K970954 — O.B. APPLICATOR TAMPONS (June 10, 1997)
  • K961119 — CAREFREE PANTYLINERS (April 17, 1996)
  • K953638 — O.B. APPLICATOR TAMPONS (October 20, 1995)
  • K941863 — O.B. TAMPON (June 27, 1994)

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