Device |
crown and bridge, long-term temporary, resin |
Regulation Description |
Temporary crown and bridge resin. |
Definition |
For the fabrication of long-term temporary crowns and bridges |
Physical State |
Polymeric, may include ceramic filler |
Technical Method |
Achieves its intended function by providing a patient-matched crown or bridge that is cemented onto a patient's dentition to restore normal mastication |
Target Area |
oral cavity |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | POW |
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 |
872.3770
|
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 Standard
|
Third Party Review
|
Accredited Persons
|