Data / Medical devices / United States / Ortho Kinetics Corp.
Ortho Kinetics Corp.: FDA-registered device maker in Vista, CA, United States, 6 510(k) clearances
Ortho Kinetics Corp. is registered with the FDA (registration 2029096) in Vista, CA, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 27, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2029096
- FEI number
- 1000160800
- Address
- 2588 Progress St Ste 13, Vista, CA, United States, 92081
- Owner or operator
- ORTHO KINETICS CORP. (9009331)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 26, 2007
- Registered through
- 2026
- Brand names listed
- AD Protraction Facemask, Facebow, Locking Facebow, NewGear Releasable Headgear, Power Coins Glow in the Dark Ligatures, Releasable Force Module, Reverese Pull Facemask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Band, Elastic, Orthodontic | ECI | 1 | Manufacturer | accessdata.fda.gov |
| Headgear, Extraoral, Orthodontic | DZB | 2 | 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 |
|---|---|---|---|---|---|---|
| April 27, 1998 | K980436 | CLASS III REVERSE PULL FACEMASK | DZB | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
| April 21, 1998 | K980245 | NITOM LOCKING FACEBOW | DZB | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
| April 20, 1998 | K980864 | POWER COINS GLOW IN THE DARK LIGATURES | ECI | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
| April 6, 1998 | K980151 | RELEASABLE FORCE MODULE | DZB | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
| March 11, 1998 | K980195 | FACEBOW | DZB | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
| March 10, 1994 | K940410 | NEW GEAR RELEASABLE HEADGEAR | DZB | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
Compare with other makers
Updated April 27, 1998. 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.