Device |
external mandibular fixator and/or distractor |
Regulation Description |
Bone plate. |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | MQN |
Premarket Review |
Division of Dental and ENT Devices
(DHT1B)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
872.4760
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
Yes
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |