Medical Device Manufacturer · US , Sheboygan , WI

American Orthodontics - FDA 510(k) Cleared Devices

45 submissions · 45 cleared · Since 1989

Recent clearances: BracePaste Prime Plus, Cleo, BracePaste Band and Build LC

Total

Cleared

Denied

American Orthodontics has 45 FDA 510(k) cleared dental devices. Based in Sheboygan, US.

Latest FDA clearance: Jun 2026. Active since 1989.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Third Party Review Group, LLC and Accelerated Device Approval Services.

American Orthodontics is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - American Orthodontics

45 devices

1-12 of 45

Cleared Jun 03, 2026

BracePaste Prime Plus

BracePaste Band and Build LC

K202276 · DYH

Dental · 3d

Cleared Oct 15, 2018

BracePaste MTP Light Cure Primer

Wire Sterilization Package with Indicators

K143117 · FRG

General Hospital · 364d

UNI-STICK PLASTIC LIGATURE, MODIFIED

K926578 · ECI

Dental · 191d

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Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Jun 08, 2026

American Orthodontics - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - American Orthodontics

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