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
| Device Type ID | 1361 |
| Device Name | Diagnostic Light, Soft Tissue Detector |
| 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 |
| 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 Description | Ultraviolet Detector. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.6350 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NXV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1361 |
| Device | Diagnostic Light, Soft Tissue Detector |
| Product Code | NXV |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ultraviolet Detector. |
| CFR Regulation Number | 872.6350 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PIERREL PHARMA S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |