Data / Medical devices / United States / Specialty Appliances, LLC
Specialty Appliances, LLC: FDA-registered device maker in Cumming, GA, United States, 6 510(k) clearances
Specialty Appliances, LLC is registered with the FDA (registration 3004158247) in Cumming, GA, United States. It lists 18 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 21, 2023. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004158247
- Address
- 4905 Hammond Industrial Drive, Cumming, GA, United States, 30041
- Owner or operator
- SPECIALTY APPLIANCES, LLC (9058539)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 12, 2003
- Registered through
- 2026
- Brand names listed
- Archwire Tubes, Chewies, Clear Image Aligners, Clear Image® Aligner, G4 NiTi Lingual Wire, Herbst AppleCore Screws, Herbst Component Parts, Indirect Bonding Tray 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 |
|---|---|---|---|---|---|---|
| August 21, 2023 | K222245 | ACR Screw System | OAT | Substantially Equivalent | Biomaterials Korea, Inc. | accessdata.fda.gov |
| January 3, 2019 | K183643 | Clear Image Aligners | NXC | Substantially Equivalent | Specialty Appliance Works, Inc. | accessdata.fda.gov |
| July 28, 2015 | K151150 | Elements | ELW | Substantially Equivalent | Pac-Dent International, Inc. | accessdata.fda.gov |
| July 16, 2015 | K150128 | GC Ortho Connect, GC Ortho Etching Gel | DYH | Substantially Equivalent | Gc Orthodontics America, Inc. | accessdata.fda.gov |
| September 25, 2007 | K071970 | CLEAR IMAGE ALIGNER | NXC | Substantially Equivalent | Specialty Appliance Works, Inc. | accessdata.fda.gov |
| April 15, 2005 | K042965 | TOMAS PIN | OAT | Substantially Equivalent | Dentaurum, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 9, 2015 | 70787 | Class II | Terminated | Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance. | The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. | accessdata.fda.gov |
Compare with other makers
- All makers of Handle, Instrument, Dental
- All makers of Wax, Dental, Intraoral
- All makers of Tube, Orthodontic
- All makers of Band, Preformed, Orthodontic
- All makers of Adhesive, Bracket And Tooth Conditioner, Resin
- All makers of Material, Impression
Updated August 21, 2023. 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.