Not currently registered with FDA under this name

Redent Nova, Ltd.

Washington, DC, United States. Named as applicant on 3 dental 510(k) clearances between 2010 and 2010. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
32010–2010
Markets registered in
44 registrations outside the US
Establishments
0—
2010: 320102020

510(k) clearances per year, 2007–2026

Registered in 4 markets

Where regulators' registries name Redent Nova, Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 3 clearancesCanada: 2 registrationsIsrael: 1 registrationsSouth Korea: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantRedent Nova, Ltd.3 clearances2010–2010Below
CanadaHealth CanadaRegistration holderREDENT NOVA LTD.22010–2010Pure Global AI
IsraelAMARRegistration holderREDENT NOVA LTD1—Pure Global AI
South KoreaMFDSManufacturerRedent Nova Ltd.12011–2011Pure 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 Redent Nova, Ltd. as the applicant.

Decided510(k)DeviceDevice type
27 Jul 2010K101172RDT3 HANDPIECE HEAD MODEL RDT3EFA Dental Belt and/or Gear Driven Handpiece
28 May 2010K100606VATEA ENDONTIC IRRIGATION SYSTEMNYL Root Canal Irrigation Air-Powered Handpiece
14 Jan 2010K092933SAF (SELF ADJUSTING FILE)EFB Dental Air-Powered Handpiece

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.