510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963746Substantially Equivalent

Ids Dental Floss with Sodium Fluoride Microdent Dental Floss with Sodium Fluoride Ap-24 Dental Floss with Sodium Fluorid

Whitehill Oral Technologies, Inc., Hazlet NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963746 is the FDA 510(k) clearance record for IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID, a class I device, cleared for Whitehill Oral Technologies, Inc. on under FDA product code JES (Floss, Dental). FDA records list 2 510(k) clearances for Whitehill Oral Technologies, Inc., from to . As of , FDA records show no recalls naming K963746.

Clearance record

Decision date
Received
(86 days to decision)
Product code
JES Floss, Dental
Regulation
21 CFR 872.6390
Device class
Class I
Review panel
Dental
Applicant
Whitehill Oral Technologies, Inc. 950 Hwy. 36, Hazlet NJ
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