| Device Type ID | 1284 |
| Device Name | Chair, Dental, With Operative Unit |
| Regulation Description | Dental Chair And Accessories. |
| 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 | 872.6250 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KLC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1284 |
| Device | Chair, Dental, With Operative Unit |
| Product Code | KLC |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Chair And Accessories. |
| CFR Regulation Number | 872.6250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DCI | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Manufacturing, Packaging Or Shipping Problem | 1 |
Break | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | A-Dec Inc | II | Jun-25-2015 |