Data / Medical devices / United States / Tangent Orthodontics
Tangent Orthodontics: FDA-registered device maker in Franklin, IN, United States, 1 510(k) clearance
Tangent Orthodontics is registered with the FDA (registration 3015259864) in Franklin, IN, United States. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 15, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015259864
- Address
- 2165 Earlywood Drive, Franklin, IN, United States, 46131
- Owner or operator
- Tangent Technologies LLC (10059559)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- January 31, 2019
- Registered through
- 2026
- Brand names listed
- Bondable Button: Eruption Appliance, Crimpable Stop, Crimpable Hook,, Ceramic Orthodontic Brackets, Elastic Separators; Elastic Thread; Elastics; Energy Chain; Elastomeric Ligatures; Rotation Wedge, Impression Tray, Orthodontic Bands, Orthodontic Buccal Tubes and Orthodontic Metal Tubes, Orthodontic Metal Brackets, Orthodontic Springs- Nickel Titanium (NiTi) ; Stainless Steel (SS) : Nickel Cobalt and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Elastic, Orthodontic | ECI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bracket, Ceramic, Orthodontic | NJM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| November 15, 2019 | K182672 | ROSA Bracket | NJM | Substantially Equivalent | Gni Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Band, Preformed, Orthodontic
- All makers of Band, Elastic, Orthodontic
- All makers of Bracket, Ceramic, Orthodontic
- All makers of Clamp, Wire, Orthodontic
- All makers of Bracket, Metal, Orthodontic
- All makers of Tube, Orthodontic
Updated November 15, 2019. 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.