Home / 510(k) Clearances / K800831

510(k) K800831

PY-CO-PROX TM DENTAL BRUSH by Block Drug Company, Inc. — Product Code EFW

K800831 is an FDA 510(k) premarket notification submitted by Block Drug Company, Inc. for the device "PY-CO-PROX TM DENTAL BRUSH". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855. Block Drug Company, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1980
Date Received
April 14, 1980
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 Block Drug Company, Inc.

  • K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM (December 20, 1994)
  • K935925 — VISION PROPHY PASTE WITH FLUORIDE (January 26, 1994)
  • K933893 — VISION PROPHY PASTE WITHOUT FLUORIDE (November 16, 1993)
  • K884533 — SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM (April 12, 1989)
  • K881974 — PROFICIENT(TM) PROPHYLAXIS ANGLE (July 25, 1988)
  • K872225 — SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER (June 30, 1987)
  • K862876 — NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM (August 29, 1986)
  • K791064 — DUO TWO LAYER DENTURE CLEANSER (October 9, 1979)
  • K780849 — DENTROL LIQUID DENTURE ADHESIVE (July 31, 1978)

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