Ortholution Co., Ltd.
Country not established
Ortholution Co., Ltd. is a medical device manufacturer, with 96 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 96
Registry facts
- Registries
- FDA GUDID 93
- FDA 510(k) 3
- Device classes
- FDA Class II 96
- Identifiers
- DUNS 689964302
What Ortholution Co., Ltd. makes
Ortholution Co., Ltd. manufactures orthodontic anchoring screws, including the ORLUS MINI SCREW, designed for use in dental and orthodontic procedures to provide skeletal anchorage during tooth movement or alignment.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries.
Catalogue
Search and filter all 96 devicesShowing 1-50 of 96
Company details
- DUNS number
- 689964302
Frequently asked questions
How many devices does Ortholution Co., Ltd. have in the registry?
The registry currently lists 96 devices for Ortholution Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ortholution Co., Ltd.'s devices?
Among its 50 most recently registered devices, Ortholution Co., Ltd. has devices listed in FDA GUDID (50 devices).
What risk classes do Ortholution Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Ortholution Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ortholution Co., Ltd. in the registry?
The most recently registered devices listed for Ortholution Co., Ltd. include ORLUS MINI SCREW 1O16212, ORLUS MINI SCREW 1H16108, ORLUS MINI SCREW 1O16106 and ORLUS MINI SCREW 1H18105.