Manufacturer registered with FDA
Jumar Corporation
Bainbridge Is, WA, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 67 registrations outside the US
- Establishments
- 1United States
Registered in 6 markets
Where regulators' registries name Jumar Corporation 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 | Jumar Corporation | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Jumar Corporation | 2 | 2001–2003 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | JUMAR CORPORATION | 2 | 2016–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | JUMAR CORPORATION | 1 | 2013–2013 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Jumar Corporation | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Jumar Corporation | 1 | 2024–2024 | 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 Jumar Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Aqualizer Mouthpiece | 2007 |
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
Jumar Corporation 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: Martin D. Lerman (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 12 Aug 1983 | K831793 | AQUALIZER MOUTHPIECE | Martin D. Lerman | KMY Preformed Tooth Positioner |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JUMAR CORPORATIONFDA reg. 3015216243 | Bainbridge Is, WA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1420333). 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.