| Device Type ID | 1129 |
| Device Name | Controller, Foot, Handpiece And Cord |
| 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 | EBW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1129 |
| Device | Controller, Foot, Handpiece And Cord |
| Product Code | EBW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Handpiece And Accessories. |
| CFR Regulation Number | 872.4200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
A-DEC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DANAHER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KALTENBACH & VOIGT GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NAKANISHI INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NAKANISHI, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PM-PRIVATSTIFTUNG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAEYANG MICROTECH CO LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TTBIO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Retraction Problem | 15 |
Device Damaged By Another Device | 8 |
Device Operates Differently Than Expected | 7 |
Unintended Movement | 5 |
Mechanical Problem | 4 |
Device Stops Intermittently | 4 |
Inappropriate Shock | 3 |
Product Quality Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Use Of Device Problem | 1 |
Incorrect Measurement | 1 |
Power Problem | 1 |
Data Problem | 1 |
Device Operational Issue | 1 |
Overheating Of Device | 1 |
Delivery System Failure | 1 |
Failure To Shut Off | 1 |
Break | 1 |
Motor | 1 |
Human Factors Issue | 1 |
Mechanical Jam | 1 |
Unexpected Shutdown | 1 |
Failure To Power Up | 1 |
Material Separation | 1 |
| Total Device Problems | 65 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | W & H DentalWerk Burmoos GMBH - Site 1 | II | Apr-11-2018 |