510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K891354Substantially Equivalent

Orthodontic Cotton Roll Holders

American Orthodontics, Sheboygan WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K891354 is the FDA 510(k) clearance record for ORTHODONTIC COTTON ROLL HOLDERS, a class I device, cleared for American Orthodontics on under FDA product code KHR (Absorber, Saliva, Paper). FDA records list 46 510(k) clearances for American Orthodontics, from to . As of , FDA records show no recalls naming K891354.

Clearance record

Decision date
Received
(38 days to decision)
Product code
KHR Absorber, Saliva, Paper
Regulation
21 CFR 872.6050
Device class
Class I
Review panel
Dental
Applicant
American Orthodontics 1714 Cambridge Ave., Sheboygan WI
Third party review
No

Clearances, product code KHR

Trailing 12 months

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

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