| Device Type ID | 1116 |
| Device Name | Light, Operating, Dental |
| Regulation Description | Dental Operating Light. |
| 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) Exempt |
| CFR Regulation Number | 872.4630 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EAZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1116 |
| Device | Light, Operating, Dental |
| Product Code | EAZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Operating Light. |
| CFR Regulation Number | 872.4630 [🔎] |
| Device Problems | |
|---|---|
Installation-Related Problem | 11 |
Device Maintenance Issue | 4 |
Mechanical Problem | 4 |
Break | 2 |
Component Falling | 2 |
Use Of Device Problem | 2 |
Misassembly During Maintenance / Repair | 1 |
Defective Device | 1 |
Detachment Of Device Or Device Component | 1 |
| Total Device Problems | 28 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Pelton & Crane / Marus / DCI Equipment / KaVo | II | Mar-28-2016 |