Manufacturer registered with FDA

Rgorithm Korea

Guemcheon-gu, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10088456Manufacturer1 clearance in five years
Device types listed
1
Brands and models
1
510(k) clearances
12023–2023
Markets registered in
1United States
Establishments
1South Korea
2023: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Rgorithm Korea currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Dental Abutment Design Software for Dental LaboratoryPNP · Class 2Dental design & orthodontic softwareMaker
TRUST
2023

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 Rgorithm Korea as the applicant.

Decided510(k)DeviceDevice type
18 Jul 2023K221107TRUSTPNP Dental Abutment Design Software for Dental Laboratory

Registered establishments

EstablishmentLocationWhat it does
RGORITHM KOREAFDA reg. 3029915447Guemcheon-gu Seoul, South KoreaManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10088456). 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.