510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800831Substantially Equivalent

Py-Co-Prox Tm Dental Brush

Block Drug Company, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800831 is the FDA 510(k) clearance record for PY-CO-PROX TM DENTAL BRUSH, a class I device, cleared for Block Drug Company, Inc. on under FDA product code EFW (Toothbrush, Manual). FDA records list 10 510(k) clearances for Block Drug Company, Inc., from to . As of , FDA records show no recalls naming K800831.

Clearance record

Decision date
Received
(24 days to decision)
Product code
EFW Toothbrush, Manual
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
Block Drug Company, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EFW

Trailing 12 months

FDA records hold no clearances under product code EFW in the trailing twelve months.

FDA records show no clearances under product code EFW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260