FDA Registration
Active
🇺🇸 United States
GC Orthodontics America Inc.
Reg #: 3010032042
·
FEI: 3010032042
·
Expires 2026
Products
31
Proprietary Names
12
Establishment Types
3
Classifications
31
Registration Details
- Registration Name
- GC Orthodontics America Inc.
- Registration Number
- 3010032042
- FEI Number
- 3010032042
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3737 W. 127th Street
- City
- Alsip
- State
- IL
- ZIP
- 60803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143667
Owner / Operator
- Firm Name
- GC Orthodontics
- Operator Number
- 10043100
- Address
- GC Orthodontics Inc., 3737 W. 127th Street
- City
- Alsip
- State
- IL
- Postal Code
- 60803
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2016-07-15 |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | Class 2 | Dental | No | 2015-06-23 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2021-12-17 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2013-07-11 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2013-07-11 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2013-08-19 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2013-01-24 |
| Band, Material, Orthodontic | DYO | Class 1 | Dental | No | 2013-01-24 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2013-07-11 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2013-01-24 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2013-01-24 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2013-01-24 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2013-07-17 |
| Facebow | KCR | Class 1 | Dental | No | 2013-01-24 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 2013-08-19 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2013-08-19 |
| Driver, Band, Orthodontic | ECT | Class 1 | Dental | No | 2013-08-19 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2013-07-11 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2021-08-03 |
| Retainer, Screw Expansion, Orthodontic | DYJ | Class 1 | Dental | No | 2013-07-17 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2019-05-29 |
| Clasp, Preformed | EHP | Class 1 | Dental | No | 2013-07-17 |
| Maintainer, Space Preformed, Orthodontic | DYT | Class 1 | Dental | No | 2013-08-19 |
| Positioner, Tooth, Preformed | KMY | Class 1 | Dental | No | 2013-08-19 |
| Setter, Band, Orthodontic | ECR | Class 1 | Dental | No | 2013-08-19 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2013-07-17 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2016-07-15 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2013-01-24 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2013-07-17 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2013-07-17 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2013-01-24 |
Proprietary Names
Mirrors
GC KommonBase
TN3
GC Ortho
GC Orthodontics
CHIC Brackets
DentaSonic
DS Interproximal Reduction
GC Ortho Connect & GC Ortho Etching Gel
Exerbites
Chewing Aligner
Orthosil
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device