Device |
instrument, diamond, dental, reprocessed |
Regulation Description |
Dental diamond instrument. |
Definition |
same as DZP except reprocessed |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | NLD |
Premarket Review |
Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Dental Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
872.4535
|
Device Class |
1
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Recognized Consensus Standard
|
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|