Custom Dental Implants, Inc.
Country not established
- Devices
- 1
What Custom Dental Implants, Inc. makes
Custom Dental Implants, Inc. manufactures dental implant systems, including the IMPLANT-ONE SYSTEM, designed for osseointegrated tooth replacement in oral and maxillofacial applications.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Implant-One System Ref K102822
510(k) 510(k)
Frequently asked questions
How many devices does Custom Dental Implants, Inc. have in the registry?
The registry currently lists 1 device for Custom Dental Implants, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Custom Dental Implants, Inc.'s devices?
Among its 1 most recently registered device, Custom Dental Implants, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Custom Dental Implants, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Custom Dental Implants, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Custom Dental Implants, Inc. in the registry?
The most recently registered devices listed for Custom Dental Implants, Inc. include IMPLANT-ONE SYSTEM.