Not currently registered with FDA under this name

Fairfax Dental, Inc.

Miami, FL, United States. Named as applicant on 1 dental 510(k) clearance between 1991 and 1991. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11991–1991
Markets registered in
35 registrations outside the US
Establishments
0—
1991: 11990200020102020

510(k) clearances per year, 1990–2026

Registered in 3 markets

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

All markets
United States: 1 clearancesCanada: 3 registrationsSouth Korea: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantFairfax Dental, Inc.1 clearances1991–1991Below
CanadaHealth CanadaRegistration holderFAIRFAX DENTAL LTD.32006–2016Pure Global AI
South KoreaMFDSManufacturerFairfax Dental Limited22001–2011Pure 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 Fairfax Dental, Inc. as the applicant.

Decided510(k)DeviceDevice type
3 Jun 1991K910446STABIDENT LOCAL ANESTHESIA SYSTEMDZM Dental Needle

Some of these clearances are listed with FDA today by another company: Fairfax MEDICAL PRODUCTS Ltd (1).

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.