Data / Medical devices / United States / American Orthodontics
American Orthodontics: FDA-registered device maker in Sheboygan, WI, United States, 24 510(k) clearances
American Orthodontics is registered with the FDA (registration 2126683) in Sheboygan, WI, United States. It lists 35 device types. The FDA files 24 510(k) clearances under its listings, the newest dated June 3, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2126683
- Address
- 3524 Washington Ave, Sheboygan, WI, United States, 53081
- Owner or operator
- AMERICAN ORTHODONTICS (2126683)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- September 26, 1988
- Registered through
- 2027
- Brand names listed
- 20/40 Ceramic Brackets (Roth, McLaughlin-Bennett-Trevisi (MBT), Standard Edgewise), 300 Series Facebows, AO Instruments - Open/Closer, AO Instruments - Scaler, Band Pusher, ART® Auxiliary Spring, Acid Etchant, Acid Etching (Gel, Semi-Gel, Liquid), Alexander Lip Bumper and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 3, 2026 | K261840 | BracePaste Prime Plus | DYH | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| August 27, 2024 | K242537 | BracePaste Fluoride Sealant | DYH | Substantially Equivalent | American Orthodontics Corp. | accessdata.fda.gov |
| July 7, 2023 | K232011 | Cleo | NJM | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| August 14, 2020 | K202276 | BracePaste Band and Build LC | DYH | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| October 15, 2018 | K181910 | BracePaste MTP Light Cure Primer | KLE | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| February 6, 2018 | K172953 | Acid Etchant | KLE | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| October 14, 2016 | K160782 | BracePaste Adhesive | DYH | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| December 14, 2012 | K122753 | EMPOWER CLEAR | NJM | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| August 23, 2012 | K121824 | ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2 | ELW | Substantially Equivalent | Lascod Spa | accessdata.fda.gov |
| August 4, 2008 | K080749 | RADIANCE | NJM | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| October 21, 2003 | K032465 | MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI | EBZ | Substantially Equivalent | Satelec | accessdata.fda.gov |
| July 21, 2000 | K001446 | LIGHT-CURED ORTHODONTIC BAND CEMENT | DYH | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| June 9, 2000 | K000358 | MULTI ADJUSTABLE FACE MASK | DZB | Substantially Equivalent | Ortho Technology | accessdata.fda.gov |
| October 29, 1996 | K963205 | ALGINMAX, ORTHOCHROME | ELW | Substantially Equivalent | American Tooth Industries | accessdata.fda.gov |
| May 24, 1996 | K961417 | GC FUJI ORTHO | DYH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 10, 1994 | K940410 | NEW GEAR RELEASABLE HEADGEAR | DZB | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
| July 30, 1992 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | EJF | Substantially Equivalent | Cdb Corp. | accessdata.fda.gov |
| April 16, 1990 | K895386 | GLASION | EMA | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| January 26, 1990 | K896249 | BANDTITE GLASS IONOMER CEMENT | EMA | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| June 23, 1989 | K893542 | DIASTEMA CLOSING KIT | EJF | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| June 12, 1989 | K893037 | NO-MIX 30 ORTHODONTIC BONDING SYSTEMS | DYH | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| March 31, 1989 | K891372 | ORTHODONTIC PLASTIC BRACKET | DYW | Substantially Equivalent | American Orthodontics | accessdata.fda.gov |
| July 21, 1987 | K872569 | TEMREX ETCHING GEL | EBF | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
| July 18, 1983 | K831495 | CURAY-ECLIPSE VISIBLE LIGHT CURED ORTHO | DYH | Substantially Equivalent | Scientific Pharmaceuticals, Inc. | accessdata.fda.gov |
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Updated June 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.