FDA Registration
Active
🇺🇸 United States
SPECIALTY APPLIANCES, LLC
Reg #: 3004158247
·
FEI: 3004158247
·
Expires 2026
Products
18
Proprietary Names
23
Establishment Types
3
Classifications
18
Registration Details
- Registration Name
- SPECIALTY APPLIANCES, LLC
- Registration Number
- 3004158247
- FEI Number
- 3004158247
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 4905 HAMMOND INDUSTRIAL DRIVE
- City
- CUMMING
- State
- GA
- ZIP
- 30041
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150128
Owner / Operator
- Firm Name
- SPECIALTY APPLIANCES, LLC
- Operator Number
- 9058539
- Address
- 4905 HAMMOND INDUSTRIAL DRIVE
- City
- Cumming
- State
- GA
- Postal Code
- 30041
- Country
- US
- Correspondent
- James H Kirk
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Crown, Preformed | ELZ | Class 1 | Dental | No | 2003-09-12 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2003-09-12 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2022-11-16 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2024-02-28 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2024-01-26 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2024-07-10 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2024-06-21 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2012-02-23 |
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2019-08-06 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2012-02-23 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2024-11-14 |
| Material, Impression | ELW | Class 2 | Dental | No | 2024-02-19 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2024-04-05 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2012-12-19 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2024-11-14 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2012-02-23 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2012-02-23 |
| Indirect Bonding Tray | QJJ | Class 1 | Dental | No | 2020-12-17 |
Proprietary Names
Orthodontic Relief Wax
Orthodontic Bands
Clear Image Aligners
Traditional Crimpable Shims
M4 Mechanism
Specialty 4 Part MiniScope Mechanism
Traditional Herbst Mechanism
Traditional Round Shims
Herbst Component Parts
Specialty MiniScope Mechanism
Herbst AppleCore Screws
Traditional Herbst Round Pivots
Traditional Herbst Hex Screw
Telescoping Crimpable Shims
OSD-1434-04C
Chewies
G4 NiTi Lingual Wire
SurgiArch
RW
Archwire Tubes
Clear Image® Aligner
M.A.R.A. Torqueing Tool
Indirect Bonding Tray
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility