Data / Medical devices / United States / Allesee Orthodontic Appliances, Inc.
Allesee Orthodontic Appliances, Inc.: FDA-registered device maker in Sturtevant, WI, United States, 1 510(k) clearance
Allesee Orthodontic Appliances, Inc. is registered with the FDA (registration 2184045) in Sturtevant, WI, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 18, 2004. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 2184045
- FEI number
- 1000128562
- Address
- 13931 Spring St, Sturtevant, WI, United States, 53177
- Owner or operator
- SYBRON DENTAL SPECIALTIES, INC. (9029565)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 2, 2002
- Registered through
- 2027
- Brand names listed
- ACCO Expander, AOB Splint, Acrylic Bonded RPE, Activators, Adaptor, Arnold Expander, Band and Loop Space Maintainer, Bionator and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aligner, Sequential | NXC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
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 18, 2004 | K040874 | RED, WHITE & BLUE | NXC | Substantially Equivalent | Allesee Orthodontic Appliances | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 24, 2014 | 67647 | Class II | Terminated | AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed gro | The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar, an over-tightened lock nut may stop the piston assembly from moving freely, subsequently preventing intended movement of the teeth. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Orthodontic
- All makers of Bracket, Metal, Orthodontic
- All makers of Positioner, Tooth, Preformed
- All makers of Retainer, Screw Expansion, Orthodontic
- All makers of Aligner, Sequential
- All makers of Maintainer, Space Preformed, Orthodontic
Updated April 1, 2014. 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.