Opusdent, Ltd.
IsraelFDA applicant, unverified
- Devices
- 5
What Opusdent, Ltd. makes
Opusdent, Ltd. manufactures dental diode lasers and laser systems, including the OPUS 20, OPUS 10 (with tooth whitening), OPUSDUO EC Dental Laser System, and OPUS Spectrum. These devices are designed for dental procedures such as soft tissue treatment, cavity detection, and tooth whitening.
The company’s portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. These devices are regulated under U.S. jurisdiction and comply with applicable U.S. medical device standards.
Catalogue
Opus 20, Model 1ST Ref K002899
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Opusduo Ec Dental Laser System Ref K021508
Regimes: 510(k) Registry: 510(k)Opus 10 Dental Diode Laser Ref K000990
Regimes: 510(k) Registry: 510(k)Opus Spectrum (A Model Of Opus 20), Model 2ND Ref K014100
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Opusdent, Ltd. have in the registry?
The registry currently lists 5 devices for Opusdent, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Opusdent, Ltd.'s devices?
Among its 5 most recently registered devices, Opusdent, Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Opusdent, Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Opusdent, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Opusdent, Ltd. in the registry?
The most recently registered devices listed for Opusdent, Ltd. include OPUS 20, MODEL 1ST, OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND, OPUSDUO EC DENTAL LASER SYSTEM and OPUS 10 DENTAL DIODE LASER.