Dental Device Guide
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Not currently registered with FDA under this name

Micro-Aire Surgical Instruments, Inc.

Valencia, CA, United States. Named as applicant on 3 dental 510(k) clearances between 1985 and 1990. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
31985–1990
Markets registered in
14502 registrations outside the US
Establishments
0—
1985: 11989: 11990: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 14 markets

Where regulators' registries name Micro-Aire Surgical Instruments, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 3 clearancesCanada: 181 registrationsSouth Korea: 92 registrationsUnited Kingdom: 57 registrationsAustralia: 51 registrationsColombia: 47 registrationsTaiwan: 21 registrationsCosta Rica: 19 registrationsBrazil: 18 registrationsPeru: 6 registrationsEuropean Union: 4 registrationsIsrael: 4 registrationsHong Kong: 1 registrationsSaudi Arabia: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantMicro-Aire Surgical Instruments, Inc.3 clearances1985–1990Below
CanadaHealth CanadaRegistration holderMICROAIRE SURGICAL INSTRUMENTS, LLCMICROAIRE SURGICAL INSTRUMENTS1812002–2025Pure Global AI
South KoreaMFDSManufacturerMicroAire Surgical Instruments LLCMicroAire Surgical Instruments, LLC · MICRO AIRE SURGICAL INSTRUMENTS INC. · +2921998–2025Pure Global AI
United KingdomMHRAManufacturerMicroAire Surgical Instruments, LLC57—Pure Global AI
AustraliaTGAManufacturerMicroaire Surgical Instruments LLC512004–2025Pure Global AI
ColombiaINVIMARegistration holderMICROAIRE SURGICAL INSTRUMENTS LLCMICROAIRE SURGICAL INSTRUMENTS47—Pure Global AI
TaiwanTFDAManufacturerMicroAire Surgical Instruments, LLCMICROAIRE SURGICAL INSTRUMENTS, INC · MICROAIRE SURGICAL INSTRUMENTS LLC. · +1212006–2021Pure Global AI
Costa RicaMinisterio de SaludManufacturerMICROAIRE SURGICAL INSTRUMENTS, LLC19—Pure Global AI
BrazilANVISAManufacturerMICROAIRE SURGICAL INSTRUMENTS, LLCMICROAIRE SURGICAL INSTRUMENTS LLC · MICROAIRE SURGICAL INSTRUMENTS · +1182001–2023Pure Global AI
PeruDIGEMIDManufacturerMICROAIRE SURGICAL INSTRUMENTS, LLC62017–2026Pure Global AI
European UnionEUDAMEDManufacturerMicroAire Surgical Instruments LLC4—Pure Global AI
IsraelAMARManufacturerMicroAire Surgical Instruments LLCMICROAIRE SURGICAL INSTRUMENTS · MicroAire Surgical Instruments, LLC4—Pure Global AI
Hong KongMDDManufacturerMicroAire Surgical Instruments, LLC12025–2025Pure Global AI
Saudi ArabiaSFDAManufacturerMicroAire Surgical Instruments. LLC1—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

510(k) clearances

Clearances on which FDA names Micro-Aire Surgical Instruments, Inc. as the applicant.

Decided510(k)DeviceDevice type
13 Jul 1990K901967DENDIA WERK BURS AND CUTTING DISCSDZP Dental Diamond Instrument
13 Oct 1989K894606MICRO-AIRE HIGH SPEED DRILL (2910-000)EFB Dental Air-Powered Handpiece
25 Mar 1985K850597MICRO-AIRE HIGH SPEED ORAL SURGERG DRILLEFB 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.