Manufacturer registered with FDA
OSSTEM ORTHODONTICS Inc.
Uiwang-si, South Korea. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 45
- 510(k) clearances
- 0as applicant
- Markets registered in
- 61,146 registrations outside the US
- Establishments
- 1South Korea
Registered in 6 markets
Where regulators' registries name OSSTEM ORTHODONTICS Inc. 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 | OSSTEM ORTHODONTICS Inc. | 8 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Osstem Orthodontics Inc. | 1,136 | — | Pure Global AI |
| China | NMPA | Registration holder | 奥齿泰正畸公司 OSSTEM ORTHODONTICS Inc.奥齿泰正畸公司OSSTEM ORTHODONTICS Inc. | 4 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OSSTEM ORTHODONTICS Inc. | 3 | 2019–2024 | Pure Global AI |
| Japan | PMDA | Registration holder | ＯＳＳＴＥＭ ＯＲＴＨＯＤＯＮＴＩＣＳ Ｉｎｃ． | 2 | 2022–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | OSSTEM ORTHODONTICS INC. | 1 | — | 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 OSSTEM ORTHODONTICS Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Maker | Clear ElectGenesis- CMAJESTY-SLCNeocrystal PlusPureSensation | 2016 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | BK MASK blueBK MASK ivoryBK MASK violetFACEMASK BL OrgFACEMASK BL RevFACEMASK VI OrgFACEMASK VI Rev | 2021 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | MTA Wire 012 NiTiMTA Wire 014 NiTiMTA Wire 35celsius thermo-active 012 NiTiMTA Wire 40celsius thermo-active 012 NiTiMTA Wire 45celsius thermo-active 012 NiTi | 2015 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | L-Tube 2mmL-Tube 3mmLPA 022 tube 1mmLPA 022 tube 2mmLPA 022 tube 3mmLPA 027 tube 1mmLPA 027 tube 2mmLPA 027 tube 3mmMTA One side flattened TubeMTA Round Tube 3 moreMTA Semi-Round TubeMTA Silver Tube 2mmMTA Silver Tube 3mm | 2015 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Forced Positioner LForced Positioner R | 2015 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | 650-08 Perforated Strip650-09 Reducer Strip(Thick)650-10 Reducer Strip(Thin)650-12 Reducer Strip(One-side) | 2024 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Dr. Unbong's M-P Tube(Molar Protraction Tube)MAJESTY TubeMAJESTY-SLMSensation MSM TubeYES2 | 2016 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Step Bend Plier LStep Bend Plier R | 2015 |
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
OSSTEM ORTHODONTICS Inc. 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: Ortho Technology, Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 Jan 2012 | K112707 | GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM | Ortho Technology, Inc. | NJM Orthodontic Ceramic Bracket |
| 18 Dec 2007 | K073045 | SAPPHIRE CERAMIC BRACKET | Ortho Technology, Inc. | NJM Orthodontic Ceramic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OSSTEM ORTHODONTICS Inc.FDA reg. 3006946041 | Uiwang-si Gyeonggi, South Korea | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10050607). 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.