Not currently registered with FDA under this name

Restore Medical, Inc.

Roseville, MN, United States. Named as applicant on 1 dental 510(k) clearance between 2004 and 2004. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12004–2004
Markets registered in
43 registrations outside the US
Establishments
0—
2004: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 4 markets

Where regulators' registries name Restore Medical, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesColombia: 1 registrationsSouth Korea: 1 registrationsTaiwan: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantRestore Medical, Inc.1 clearances2004–2004Below
ColombiaINVIMAManufacturerRESTORE MEDICAL, INC .1—Pure Global AI
South KoreaMFDSManufacturerRestore Medical , Inc12005–2005Pure Global AI
TaiwanTFDAManufacturerRESTORE MEDICAL, INC.12009–2009Pure 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

510(k) clearances

Clearances on which FDA names Restore Medical, Inc. as the applicant.

Decided510(k)DeviceDevice type
28 Jul 2004K040417PILLAR PALATAL IMPLANT SYSTEMLRK Anti-Snoring Device

Sources

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 of the most recent filing, which can be a US agent.