Newton Implant Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Newton Implant Systems, Inc. makes
Newton Implant Systems, Inc. manufactures dental implant systems, including the S-Plant and Ni2 Implant Systems, designed for oral and maxillofacial reconstruction. These products are intended for use in surgical procedures to replace missing teeth with titanium-based implants that integrate with bone tissue. The systems include components such as abutments and implant fixtures tailored for dental restoration applications.
The company’s dental implant systems are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) database, adhering to US regulatory requirements for implantable dental devices. The manufacturer operates from the United States.
Catalogue
S-Plant Dental Implant System Ref K221866
Regimes: 510(k) Registry: 510(k)Ni2 Implant System Ref K221847
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Newton Implant Systems, Inc. have in the registry?
The registry currently lists 2 devices for Newton Implant Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Newton Implant Systems, Inc.'s devices?
Among its 2 most recently registered devices, Newton Implant Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Newton Implant Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Newton Implant Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Newton Implant Systems, Inc. in the registry?
The most recently registered devices listed for Newton Implant Systems, Inc. include S-Plant Dental Implant System and Ni2 Implant System.