Registered with FDA
White Oak Orthodontic Products
Mount Joy, PA, United States. Lists 19 dental device types with FDA across 1 registered establishment.
- Device types listed
- 19
- Brands and models
- 24
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name White Oak Orthodontic Products as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | White Oak Orthodontic Products | 19 device types | — | Below |
| South Korea | MFDS | Manufacturer | White Oak Orthodontic Products | 1 | 2016–2016 | 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 White Oak Orthodontic Products currently lists, by FDA device type, with the brand and model names on the listing.
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
White Oak Orthodontic Products 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 Kinetics Corp. (1), Cdb Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Mar 1998 | K980195 | FACEBOW | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 30 Jul 1992 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | Cdb Corporation | EJF Orthodontic Metal Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WHITE OAK ORTHODONTIC PRODUCTSFDA reg. 3009827000 | Mount Joy, PA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042063). 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.