| Device Type ID | 1234 |
| Device Name | Handpiece, Direct Drive, Ac-powered |
| 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 | EKX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1234 |
| Device | Handpiece, Direct Drive, Ac-powered |
| Product Code | EKX |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Handpiece And Accessories. |
| CFR Regulation Number | 872.4200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ASEPTICO, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
J. MORITA CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
META BIOMED, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO-NX CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSTELL AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SAESHIN PRECISION CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Overheating Of Device | 135 |
Unintended Movement | 23 |
Dent In Material | 17 |
Retraction Problem | 15 |
Failure To Service | 4 |
Device Maintenance Issue | 4 |
Device Damaged By Another Device | 4 |
Device Handling Problem | 4 |
Inappropriate Shock | 3 |
Device Operates Differently Than Expected | 3 |
Failure To Calibrate | 3 |
Electrical /Electronic Property Problem | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Fluid Leak | 2 |
Mechanical Problem | 2 |
Detachment Of Device Or Device Component | 2 |
Temperature Problem | 1 |
Display Or Visual Feedback Problem | 1 |
Calibration Problem | 1 |
Component Falling | 1 |
Material Separation | 1 |
Device Issue | 1 |
Motor | 1 |
Detachment Of Device Component | 1 |
Unintended Electrical Shock | 1 |
Patient-Device Incompatibility | 1 |
Fail-Safe Problem | 1 |
Failure To Auto Stop | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Appropriate Term/Code Not Available | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 240 |