| Device |
diagnostic light, soft tissue detector |
| Regulation Description |
Ultraviolet detector. |
| Definition |
To be used as an aid in the detection or visualization of abnormalities of intraoral soft tissue. An adjunct to traditional intraoral examination by incandescent light to enhance the visualization of oral mucosal abnormalities |
| Physical State |
The device consists of a light source with light guide cable or a handpiece based light emitting apparatus. Added components may or may not block or filter out light inundesired frequencies. The reflected light reveals tissue characteristics that are abnormal, or are suspected to be abnormal. |
| Technical Method |
The device emits a light in a specific wavelength range causing intraoral tissues to fluoresce or return or reflect light in another wavelength range in a detectable manner. |
| Target Area |
Intraoral soft tissues. |
| Regulation Medical Specialty |
Dental |
| Review Panel |
Dental |
|---|
| Product Code | NXV |
|---|
| 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 |
872.6350
|
|---|
| 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
|
