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Specialty Appliance Works, Inc.

United StatesFDA applicant, unverified

Devices
3
FDA recalls
10

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Specialty Appliance Works, Inc. makes

Specialty Appliance Works, Inc. manufactures dental orthodontic aligners, including the CLEAR IMAGE ALIGNER, and acrylic Herbst splint appliances for bite correction and tooth alignment.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • Clear Image Aligner Ref K071970

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Acrylic Herbst Splint Appliance Ref K083209

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Clear Image Aligners Ref K183643

    Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls10

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 10 recalls initiated by Specialty Appliance Works, Inc., initiated on 2015-03-09. By recorded status: 10 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2015

    • 9 Mar 2015 Z-1502-2015 Class II Terminated The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico,…
      Full distribution text Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
    • 9 Mar 2015 Z-1503-2015 Class II Terminated The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico,…
      Full distribution text Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
    • 9 Mar 2015 Z-1504-2015 Class II Terminated The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico,…
      Full distribution text Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
    • 9 Mar 2015 Z-1505-2015 Class II Terminated The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico,…
      Full distribution text Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
    • 9 Mar 2015 Z-1506-2015 Class II Terminated The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico,…
      Full distribution text Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
    • 9 Mar 2015 Z-1507-2015 Class II Terminated The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico,…
      Full distribution text Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
    • 9 Mar 2015 Z-1508-2015 Class II Terminated The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico,…
      Full distribution text Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
    • 9 Mar 2015 Z-1509-2015 Class II Terminated The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico,…
      Full distribution text Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
    • 9 Mar 2015 Z-1510-2015 Class II Terminated The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico,…
      Full distribution text Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
    • 9 Mar 2015 Z-1511-2015 Class II Terminated The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. Distribution: Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico,…
      Full distribution text Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.

Frequently asked questions

How many devices does Specialty Appliance Works, Inc. have in the registry?

The registry currently lists 3 devices for Specialty Appliance Works, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Specialty Appliance Works, Inc.'s devices?

Among its 3 most recently registered devices, Specialty Appliance Works, Inc. has devices listed in FDA 510(k) (3 devices).

What risk classes do Specialty Appliance Works, Inc.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Specialty Appliance Works, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Specialty Appliance Works, Inc.?

FDA recall records list 10 recalls initiated by Specialty Appliance Works, Inc., the most recent initiated on 9 Mar 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Specialty Appliance Works, Inc. in the registry?

The most recently registered devices listed for Specialty Appliance Works, Inc. include CLEAR IMAGE ALIGNER, ACRYLIC HERBST SPLINT APPLIANCE and Clear Image Aligners.

Generated automatically from registry data and not verified by a human reviewer.