Device |
bracket, metal, orthodontic, reprocessed |
Regulation Description |
Orthodontic appliance and accessories. |
Definition |
Intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf). |
Regulation Medical Specialty |
Dental |
Review Panel |
Dental |
Product Code | NQS |
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 |
872.5410
|
Device Class |
1
|
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 Standards
|
Third Party Review
|
Accredited Persons
|