510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K931353Substantially Equivalent

Floss Plus

Floss Plus, Inc., Muskego WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K931353 is the FDA 510(k) clearance record for FLOSS PLUS, a class I device, cleared for Floss Plus, Inc. on under FDA product code JES (Floss, Dental). FDA records list one 510(k) clearance for Floss Plus, Inc. As of , FDA records show no recalls naming K931353.

Clearance record

Decision date
Received
(132 days to decision)
Product code
JES Floss, Dental
Regulation
21 CFR 872.6390
Device class
Class I
Review panel
Dental
Applicant
Floss Plus, Inc. S72 W13839 Woods Dr., Muskego WI
510(k) summary
Statement
Third party review
No

Clearances, product code JES

Trailing 12 months

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

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