| Device |
caries detection product with drug or biologic |
| Definition |
Intended to aid in the detection of tooth decay by measuring increased visible light, fluorescence, or luminescence induced by caries-activated drug or biologic. |
| Physical State |
This product is comprised of intraoral imaging system with applicator mechanism for dispensing the drug or biologic. The intraoral imaging system contains a camera and is used with compatible imaging software. |
| Technical Method |
Product dispenses the drug or biologic onto accessible teeth in the patient’s mouth. The drug or biologic binds to caries-related constituents naturally occurring in the mouth, which induces the drug or biologic to give off increased visible light, fluorescence, or luminescence. Images of the detected visible light, fluorescence, or luminescence are used by the dental healthcare professional to see the carious lesions activity and aid in development of treatment planning. |
| Target Area |
Accessible tooth surfaces |
| Review Panel |
Dental |
|---|
| Product Code | QJX |
|---|
| Premarket Review |
Division of Dental and ENT Devices
(DHT1B)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
