Device |
dental navigation system |
Regulation Description |
Bone cutting instrument and accessories. |
Definition |
Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures. |
Physical State |
The dental navigation system is comprised of navigation software, user interface, patient tracker, dental instrument tracker, display screen and accessories. |
Technical Method |
The navigation system software receives in real-time the position of a dental instrument and the patient which is displayed on a screen. |
Target Area |
Intraoral for general dentistry procedures |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | QRY |
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 |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |