510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K882572Substantially Equivalent

Doctor Kolynos Toothbrush

Whitehall Laboratories, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882572 is the FDA 510(k) clearance record for DOCTOR KOLYNOS TOOTHBRUSH, a class I device, cleared for Whitehall Laboratories, Inc. on under FDA product code EFW (Toothbrush, Manual). FDA records list 2 510(k) clearances for Whitehall Laboratories, Inc., from to . As of , FDA records show no recalls naming K882572.

Clearance record

Decision date
Received
(299 days to decision)
Product code
EFW Toothbrush, Manual
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
Whitehall Laboratories, Inc. 685 Third Ave., New York NY
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