510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880589Substantially Equivalent

Rota-Dent Tooth Cleaner

Pro-Dentec, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880589 is the FDA 510(k) clearance record for ROTA-DENT TOOTH CLEANER, a class I device, cleared for Pro-Dentec on under FDA product code JEQ (Toothbrush, Powered). FDA records list 2 510(k) clearances for Pro-Dentec, from to . As of , FDA records show no recalls naming K880589.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JEQ Toothbrush, Powered
Regulation
21 CFR 872.6865
Device class
Class I
Review panel
Dental
Applicant
Pro-Dentec 333 W. Wacker Dr., Chicago IL
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