Data / Medical devices / United States / GC Orthodontics America Inc.
GC Orthodontics America Inc.: FDA-registered device maker in Alsip, IL, United States, 5 510(k) clearances
GC Orthodontics America Inc. is registered with the FDA (registration 3010032042) in Alsip, IL, United States. It lists 31 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 16, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010032042
- Address
- 3737 W. 127th Street, Alsip, IL, United States, 60803
- Owner or operator
- GC Orthodontics (10043100)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler
- First device listed
- January 24, 2013
- Registered through
- 2026
- Brand names listed
- CHIC Brackets, Chewing Aligner, DS Interproximal Reduction, DentaSonic, Exerbites, GC KommonBase, GC Ortho, GC Ortho Connect & GC Ortho Etching Gel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Retractor, Dental | EIF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Adhesive, Bracket And Tooth Conditioner, Resin | DYH | 2 | Complaint file establishment | accessdata.fda.gov |
| Aligner, Bracket, Orthodontic | ECQ | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Band, Elastic, Orthodontic | ECI | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Band, Material, Orthodontic | DYO | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clasp, Preformed | EHP | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Driver, Band, Orthodontic | ECT | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Facebow | KCR | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Complaint file establishment | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment | accessdata.fda.gov |
| Maintainer, Space Preformed, Orthodontic | DYT | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Setter, Band, Orthodontic | ECR | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| July 16, 2015 | K150128 | GC Ortho Connect, GC Ortho Etching Gel | DYH | Substantially Equivalent | Gc Orthodontics America, Inc. | accessdata.fda.gov |
| May 7, 2015 | K143667 | GC KommonBase | DYH | Substantially Equivalent | Gc Orthodontics America, Inc. | accessdata.fda.gov |
| December 21, 2012 | K123092 | CERAMIN BRACKETS Z | NJM | Substantially Equivalent | Tomy, Inc. | accessdata.fda.gov |
| December 13, 2012 | K123094 | ORTHODONTIC CERAMIC BRACKETS | NJM | Substantially Equivalent | Tomy, Inc. | accessdata.fda.gov |
| December 6, 2010 | K093749 | GC AADVA IMPLANT SYSTEM | DZE | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Retainer, Screw Expansion, Orthodontic
- All makers of Clamp, Wire, Orthodontic
- All makers of Bracket, Metal, Orthodontic
- All makers of Aligner, Bracket, Orthodontic
Updated July 16, 2015. 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.