510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K885056Substantially Equivalent

Twixel(tm)

Fouts Development, Inc., High Point NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885056 is the FDA 510(k) clearance record for TWIXEL(TM), a class I device, cleared for Fouts Development, Inc. on under FDA product code JES (Floss, Dental). FDA records list one 510(k) clearance for Fouts Development, Inc. As of , FDA records show no recalls naming K885056.

Clearance record

Decision date
Received
(28 days to decision)
Product code
JES Floss, Dental
Regulation
21 CFR 872.6390
Device class
Class I
Review panel
Dental
Applicant
Fouts Development, Inc. P.O. Box 6354, High Point NC
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