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510(k) K892264

ORALCHEK SUPER-SOFT BRUSH by Pfizer, Inc. — Product Code EFW

K892264 is an FDA 510(k) premarket notification submitted by Pfizer, Inc. for the device "ORALCHEK SUPER-SOFT BRUSH". The FDA issued a decision of Substantially Equivalent on June 14, 1989. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855. Pfizer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1989
Date Received
April 5, 1989
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 Pfizer, Inc.

  • K181102 — ThermaCare Quick Therapy TENS (September 15, 2018)
  • K991620 — VISINE FOR CONTACTS (September 24, 1999)
  • K892360 — WATER JEL STERILE GEL-SOAKED BURN DRESSING (June 5, 1989)
  • K881378 — PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (June 17, 1988)
  • K854726 — MEDI-WIPES UNITED ANTISEPTIC SKIN PREP (February 24, 1986)
  • K850413 — MEC HIP BOLT (July 15, 1985)
  • K850403 — MEC DISTAL FEMORAL BOLT (July 15, 1985)
  • K850840 — HOWMEDICA THREADED ACETABULAR COMPONENT (July 15, 1985)
  • K850443 — MEC ROD CONNECTOR (July 15, 1985)
  • K851971 — SERIES 7000/HOLTER RECORDER (June 20, 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