Rgorithm Korea
South KoreaFDA applicant, unverified FDA FEI 3029915447
Rgorithm Korea is a medical device manufacturer, with 2 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 13 Nov 2026.
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 1
- FDA GUDID 1
- Device classes
- FDA Class II 2
- Identifiers
- FDA FEI 3029915447
- DUNS 695116627
At a glance
Market reach
- United States
- FDA FEI
What Rgorithm Korea makes
Rgorithm Korea develops CAD/CAM software designed for dental applications, including digital planning and milling solutions for restorative procedures. Their products are tailored for use in dental laboratories and clinics to streamline workflows for crowns, bridges, and other dental restorations.
The company’s portfolio is regulated under Class II medical devices in the US, with devices authorised through FDA pathways including 510(k) clearances and UDI compliance. Their products are listed in the FDA’s regulatory databases, and the company operates from the United States.
Catalogue
- Regimes: 510(k) Registry: GUDID
Trust Ref K221107
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3029915447
- DUNS number
- 695116627
- Address
- #A 1502,1503, 606, seobusaet-gil, guemcheon-gu, Republic of Korea, Guemcheon-gu Seoul
Frequently asked questions
How many devices does Rgorithm Korea have in the registry?
The registry currently lists 2 devices for Rgorithm Korea. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rgorithm Korea's devices?
Among its 2 most recently registered devices, Rgorithm Korea has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Rgorithm Korea's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Rgorithm Korea's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rgorithm Korea in the registry?
The most recently registered devices listed for Rgorithm Korea include TRUST V1.0 and TRUST.