510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003517Substantially Equivalent

Otres Toothbrush Sanitizer Model Tb100w

Otres, LLC, Lisle IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003517 is the FDA 510(k) clearance record for OTRES TOOTHBRUSH SANITIZER MODEL TB100W, a class I device, cleared for Otres, LLC on under FDA product code MCF (Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile). FDA records list one 510(k) clearance for Otres, LLC. As of , FDA records show no recalls naming K003517.

Clearance record

Decision date
Received
(204 days to decision)
Product code
MCF Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
Otres, LLC 4225 Naperville Rd., Lisle IL
510(k) summary
Statement
Third party review
No

Clearances, product code MCF

Trailing 12 months

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

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