Manufacturer registered with FDA
Ortho Kinetics Corp.
Vista, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 7
- 510(k) clearances
- 71994–1998
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Ortho Kinetics Corp. 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 | Ortho Kinetics Corp. | 7 clearances | 1994–1998 | Below |
| South Korea | MFDS | Manufacturer | Ortho Kinetics Corporation | 1 | 2015–2015 | 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 Ortho Kinetics Corp. 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 Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | AD Protraction FacemaskFacebowLocking FacebowNewGear Releasable HeadgearReleasable Force ModuleReverese Pull Facemask | 2007 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Power Coins Glow in the Dark Ligatures | 2007 |
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 Ortho Kinetics Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Sep 1998 | K982088 | AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM | DZB Orthodontic Extraoral Headgear |
| 27 Apr 1998 | K980436 | CLASS III REVERSE PULL FACEMASK | DZB Orthodontic Extraoral Headgear |
| 21 Apr 1998 | K980245 | NITOM LOCKING FACEBOW | DZB Orthodontic Extraoral Headgear |
| 20 Apr 1998 | K980864 | POWER COINS GLOW IN THE DARK LIGATURES | ECI Orthodontic Elastic Band |
| 6 Apr 1998 | K980151 | RELEASABLE FORCE MODULE | DZB Orthodontic Extraoral Headgear |
| 11 Mar 1998 | K980195 | FACEBOW | DZB Orthodontic Extraoral Headgear |
| 10 Mar 1994 | K940410 | NEW GEAR RELEASABLE HEADGEAR | DZB Orthodontic Extraoral Headgear |
Some of these clearances are listed with FDA today by another company: Ortho Organizers, Inc. (3), Sybron Dental Specialties (1), American Orthodontics (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ORTHO KINETICS CORP.FDA reg. 2029096 | VISTA, CA, United States | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9009331). 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.