Dental Device Guide
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Manufacturer registered with FDA

GuideMia Technologies, LLC

Los Alamitos, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10042869Manufacturer
Device types listed
1
Brands and models
1
510(k) clearances
12017–2017
Markets registered in
32 registrations outside the US
Establishments
1United States
2017: 120102020

510(k) clearances per year, 2007–2026

Registered in 3 markets

Where regulators' registries name GuideMia Technologies, LLC as the manufacturer or the registration holder of a device.

All markets
United States: 1 device types listedIsrael: 1 registrationsSouth Korea: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerGuideMia Technologies, LLC1 clearances2017–2017Below
IsraelAMARManufacturerGuideMia Technologies, LLC1—Pure Global AI
South KoreaMFDSManufacturerGuideMia Technologies LLC12014–2014Pure 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 GuideMia Technologies, LLC currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Orthodontic SoftwarePNN · Class 2Dental design & orthodontic softwareMaker
GuideMia OrthoPlus Software
2017

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names GuideMia Technologies, LLC as the applicant.

Decided510(k)DeviceDevice type
24 Mar 2017K162850GuideMia Ortho+PNN Orthodontic Software

Registered establishments

EstablishmentLocationWhat it does
GUIDEMIA TECHNOLOGIES, LLCFDA reg. 3013634985Buena Park, CA, United StatesManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10042869). 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.