| Device Type ID | 1330 |
| Device Name | Laser, Fluorescence Caries Detection |
| Regulation Description | Laser Fluorescence Caries Detection Device. |
| 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 | 872.1745 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NBL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1330 |
| Device | Laser, Fluorescence Caries Detection |
| Product Code | NBL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laser Fluorescence Caries Detection Device. |
| CFR Regulation Number | 872.1745 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CARL ZEISS MEDITEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTEK THERAPEUTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Overheating Of Device | 2 |
Battery | 1 |
Failure To Service | 1 |
Fire | 1 |
Sparking | 1 |
| Total Device Problems | 6 |