510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K831254Substantially Equivalent

Dental Floss Holder

Sewon Industry, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831254 is the FDA 510(k) clearance record for DENTAL FLOSS HOLDER, a class I device, cleared for Sewon Industry on under FDA product code JES (Floss, Dental). FDA records list 7 510(k) clearances for Sewon Industry, from to . As of , FDA records show no recalls naming K831254.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JES Floss, Dental
Regulation
21 CFR 872.6390
Device class
Class I
Review panel
Dental
Applicant
Sewon Industry 803 N. Front St. Suite 3, Mchenry IL
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