Device |
dental barriers and sleeves |
Regulation Description |
Surgical drape and drape accessories. |
Definition |
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients. |
Physical State |
Clear polymer film |
Technical Method |
Adhesively applied to patient contacting surfaces of reusable dental instruments/devices. |
Target Area |
For devices to be used in dental surgery. |
Regulation Medical Specialty |
General & Plastic Surgery |
Review Panel |
Dental |
Product Code | PEM |
Premarket Review |
Division of Dental and ENT Devices
(DHT1B)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
878.4370
|
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
|
Third Party Review
|
Accredited Persons
|