510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921601Substantially Equivalent

Ultradent Prod Retract Cord/accessory Product Line

Ultradent Products Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921601 is the FDA 510(k) clearance record for ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE, a class I device, cleared for Ultradent Products, Inc. on under FDA product code JES (Floss, Dental). FDA records list 104 510(k) clearances for Ultradent Products, Inc., from to . As of , FDA records show no recalls naming K921601.

Clearance record

Decision date
Received
(74 days to decision)
Product code
JES Floss, Dental
Regulation
21 CFR 872.6390
Device class
Class I
Review panel
Dental
Applicant
Ultradent Products, Inc. 1345 E. 3900 So., Salt Lake City UT
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JES, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260