| Device Type ID | 1147 |
| Device Name | Handpiece, Belt And/or Gear Driven, Dental |
| Regulation Description | Dental Handpiece 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 | 872.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EFA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1147 |
| Device | Handpiece, Belt And/or Gear Driven, Dental |
| Product Code | EFA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Handpiece And Accessories. |
| CFR Regulation Number | 872.4200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DANAHER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KALTENBACH & VOIGT GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Overheating Of Device | 86 |
Detachment Of Device Or Device Component | 1 |
Detachment Of Device Component | 1 |
| Total Device Problems | 88 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Dental EZ Group Star Dental Division | II | Jul-17-2014 |