510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896245Substantially Equivalent

Plak Trac Powered Toothbrush

Windmere Corp., Miami Lakes FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896245 is the FDA 510(k) clearance record for PLAK TRAC POWERED TOOTHBRUSH, a class I device, cleared for Windmere Corp. on under FDA product code JEQ (Toothbrush, Powered). FDA records list 7 510(k) clearances for Windmere Corp., from to . As of , FDA records show no recalls naming K896245.

Clearance record

Decision date
Received
(149 days to decision)
Product code
JEQ Toothbrush, Powered
Regulation
21 CFR 872.6865
Device class
Class I
Review panel
Dental
Applicant
Windmere Corp. 5980 Miami Lades Dr., Miami Lakes FL
Third party review
No

Clearances, product code JEQ

Trailing 12 months

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

FDA records show no clearances under product code JEQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JEQ, 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