Manufacturer registered with FDA
GC Orthodontics
Alsip, IL, United States. Lists 31 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 31
- Brands and models
- 22
- 510(k) clearances
- 22015–2015
- Markets registered in
- 3262 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name GC Orthodontics as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | GC Orthodontics | 2 clearances | 2015–2015 | Below |
| Canada | Health Canada | Registration holder | GC ORTHODONTICS AMERICA INC. | 250 | 2015–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | GC ORTHODONTICS AMERICA INC. | 12 | 2021–2021 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What GC Orthodontics currently lists, by FDA device type, with the brand and model names on the listing.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names GC Orthodontics as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Jul 2015 | K150128 | GC Ortho Connect, GC Ortho Etching Gel | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 7 May 2015 | K143667 | GC KommonBase | DYH Resin Bracket and Tooth Conditioner Adhesive |
Some of these clearances are listed with FDA today by another company: GC America Inc. (2), Specialty Appliances, LLC (1).
Also lists devices cleared under other names
GC Orthodontics 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: Tomy, Inc. (2), GC America Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Dec 2012 | K123092 | CERAMIN BRACKETS Z | Tomy, Inc. | NJM Orthodontic Ceramic Bracket |
| 13 Dec 2012 | K123094 | ORTHODONTIC CERAMIC BRACKETS | Tomy, Inc. | NJM Orthodontic Ceramic Bracket |
| 6 Dec 2010 | K093749 | GC AADVA IMPLANT SYSTEM | GC America Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GC Orthodontics America Inc.FDA reg. 3010032042 | Alsip, IL, United States | Complaint file establishment, Manufacturer, Repacker / relabeler |
Other names on FDA records
GC Orthodontics America Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043100). 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.