| Device |
dental stereotaxic instrument |
| Regulation Description |
Bone cutting instrument and accessories. |
| Definition |
To facilitate dental implant placement in patients that are partially endentulous or edentulous. |
| Physical State |
A cart mounted system that physically attaches to the patient as well as the surgical instrument in order to detect the location of the device in physical space. |
| Technical Method |
The device uses stereo cameras to detect tracking devices placed on both the surgical instrument as well as on the patient. The tracked image is then placed on a screen with predetermined anatomical landmarks to assist the clinician with the surgical placement. |
| Target Area |
Intraoral surgical procedures in the mouth. |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | PLV |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
872.4120
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Third Party Review |
Not Third Party Eligible |
