Data / Medical devices / South Korea / OSSTEM ORTHODONTICS Inc.
OSSTEM ORTHODONTICS Inc.: FDA-registered device maker in Uiwang-si Gyeonggi, South Korea, 2 510(k) clearances
OSSTEM ORTHODONTICS Inc. is registered with the FDA (registration 3006946041) in Uiwang-si Gyeonggi, South Korea. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 13, 2012. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006946041
- Address
- (Ojeon-dong, Byeoksantechnopia) A-1203, 1204 13 Ojeongongeop-gil, Uiwang-si Gyeonggi, South Korea, 16072
- Owner or operator
- OSSTEM ORTHODONTICS Inc. (10050607)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 8, 2015
- Registered through
- 2027
- Brand names listed
- 650-08 Perforated Strip, 650-09 Reducer Strip(Thick), 650-10 Reducer Strip(Thin), 650-12 Reducer Strip(One-side), BK MASK blue, BK MASK ivory, BK MASK violet, Clear Elect and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Material, Orthodontic | DYO | 1 | Manufacturer | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Manufacturer | accessdata.fda.gov |
| Setter, Band, Orthodontic | ECR | 1 | Manufacturer | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Manufacturer | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 13, 2012 | K112707 | GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM | NJM | Substantially Equivalent | Ortho Technology, Inc. | accessdata.fda.gov |
| December 18, 2007 | K073045 | SAPPHIRE CERAMIC BRACKET | NJM | Substantially Equivalent | Ortho Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bracket, Ceramic, Orthodontic
- All makers of Wire, Orthodontic
- All makers of Strip, Polishing Agent
- All makers of Plier, Orthodontic
- All makers of Tube, Orthodontic
- All makers of Setter, Band, Orthodontic
Updated January 13, 2012. 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.