# American Orthodontics

- Location (FDA's records): Sheboygan, WI
- FDA decisions: 46 (1989–2026): 46 510(k) clearances
- Names in FDA's records: American Orthodontics (45); American Orthodontics Corp. (1)
- Product codes: EJF (22), DYH (8), NJM (3), KMY (2), KLE (2), KHR (1), EMA (1), ECI (1), DYW (1), DYJ (1), FJF (1), EBI (1)
- 510(k) review time since 2016: median 3 days, against 124 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Unitek Corp.: 1 (https://510kreport.com/company/unitek)
- Scientific Pharmaceuticals, Inc.: 1 (https://510kreport.com/company/scientific-pharmaceuticals)
- E Dental Products: 1 (https://510kreport.com/company/e-dental-products)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)
- 3M Company: 1 (https://510kreport.com/company/3m)
- Safe Secure Packaging Co., Ltd.: 1 (https://510kreport.com/company/safe-secure-packaging)
- Steritec Products Mfg Co, Inc.: 1 (https://510kreport.com/company/steritec-products-mfg)
- Ultradent Products, Inc.: 1 (https://510kreport.com/company/ultradent-products)

## Firms that cite its devices most
- Tp Orthodontics, Inc.: 2 (https://510kreport.com/company/tp-orthodontics)
- Ormco Corp.: 1 (https://510kreport.com/company/ormco)
- DiaDent Group International: 1 (https://510kreport.com/company/diadent-group-international)
- Progressive Technology, Inc.: 1 (https://510kreport.com/company/progressive-technology)

## Its most-cited devices
- K080749: Radiance (2008), cited by 4
- K172953: Acid Etchant (2018), cited by 2
- K160782: BracePaste Adhesive (2016), cited by 1
- K122753: Empower Clear (2012), cited by 1

## Recent decisions
- K261840: BracePaste Prime Plus (Jun 3, 2026)
- K242537: BracePaste Fluoride Sealant (Aug 27, 2024)
- K232011: Cleo (Jul 7, 2023)
- K202276: BracePaste Band and Build LC (Aug 14, 2020)
- K181910: BracePaste MTP Light Cure Primer (Oct 15, 2018)
- K172953: Acid Etchant (Feb 6, 2018)
- K160782: BracePaste Adhesive (Oct 14, 2016)
- K143117: Wire Sterilization Package with Indicators (Oct 29, 2015)

Source page: https://510kreport.com/company/american-orthodontics