Device |
unit, x-ray, intraoral |
Regulation Description |
Intraoral source x-ray system. |
Regulation Medical Specialty |
Dental |
Review Panel |
Radiology |
Product Code | EAP |
Premarket Review |
Office of In Vitro Diagnostics and Radiological Health
(OIR)
|
Submission Type |
510(k)
|
Regulation Number |
872.1810
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Recognized Consensus Standards
|
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|