Clevaligner, Ltd.
IsraelFDA applicant, unverified
- Devices
- 1
What Clevaligner, Ltd. makes
Clevaligner, Ltd. develops orthodontic treatment planning software designed to assist dental professionals in creating digital treatment plans for aligner therapy. The software integrates with intraoral scans and imaging to generate customised aligner sequences for patient-specific cases.
The company’s portfolio is regulated under FDA’s Class II device classification and requires 510(k) clearance. The software is listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Clevaligner Software (V1.0.0) Ref K233616
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Clevaligner, Ltd. have in the registry?
The registry currently lists 1 device for Clevaligner, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Clevaligner, Ltd.'s devices?
Among its 1 most recently registered device, Clevaligner, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Clevaligner, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Clevaligner, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Clevaligner, Ltd. in the registry?
The most recently registered devices listed for Clevaligner, Ltd. include Clevaligner Software (V1.0.0).