Manufacturer registered with FDA
Specialty Appliances, LLC
Cumming, GA, United States. Lists 18 dental device types with FDA across 1 registered establishment.
- Device types listed
- 18
- Brands and models
- 23
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Specialty Appliances, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Sequential AlignerNXC · Class 2 | Clear aligners | Maker | Clear Image AlignersClear Image® Aligner | 2007 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Lister | — | 2024 |
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | — | 2024 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Lister | — | 2003 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | G4 NiTi Lingual WireSurgiArch | 2012 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | Archwire Tubes | 2012 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | M.A.R.A. Torqueing Tool | 2012 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | — | 2022 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Bands | 2012 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Herbst AppleCore ScrewsHerbst Component PartsM4 MechanismSpecialty 4 Part MiniScope MechanismSpecialty MiniScope MechanismTelescoping Crimpable ShimsTraditional Crimpable ShimsTraditional Herbst Hex ScrewTraditional Herbst MechanismTraditional Herbst Round Pivots 1 moreTraditional Round Shims | 2012 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Lister | Chewies | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Orthodontic Relief Wax | 2024 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | RW | 2024 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | — | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | OSD-1434-04C | 2024 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2024 |
| Preformed CrownELZ · Class 1 | — | Maker | — | 2003 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | Indirect Bonding Tray | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Specialty Appliances, LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Specialty Appliance Works, Inc. (2), Biomaterials Korea, Inc. (1), Pac-Dent International, Inc. (1), GC Orthodontics (1), Dentaurum (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Aug 2023 | K222245 | ACR Screw System | Biomaterials Korea, Inc. | OAT Orthodontic Endosseous Implant |
| 3 Jan 2019 | K183643 | Clear Image Aligners | Specialty Appliance Works, Inc. | NXC Sequential Aligner |
| 28 Jul 2015 | K151150 | Elements | Pac-Dent International, Inc. | ELW Impression Material |
| 16 Jul 2015 | K150128 | GC Ortho Connect, GC Ortho Etching Gel | GC Orthodontics | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 25 Sep 2007 | K071970 | CLEAR IMAGE ALIGNER | Specialty Appliance Works, Inc. | NXC Sequential Aligner |
| 15 Apr 2005 | K042965 | TOMAS PIN | Dentaurum | OAT Orthodontic Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SPECIALTY APPLIANCES, LLCFDA reg. 3004158247 | CUMMING, GA, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9058539). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.