| Device Type ID | 1104 |
| Device Name | Driver, Wire, And Bone Drill, Manual |
| Regulation Description | Bone Cutting Instrument 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 | 872.4120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DZJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 1104 |
| Device | Driver, Wire, And Bone Drill, Manual |
| Product Code | DZJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Cutting Instrument And Accessories. |
| CFR Regulation Number | 872.4120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
KLS MARTIN GMBH And CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDICAL MODELING INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROPEL ORTHODONTICS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROPEL ORTHODONTICS LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Unintended Power Up | 12 |
Device Remains Activated | 9 |
Break | 7 |
Unintended Movement | 3 |
Peeled / Delaminated | 2 |
Overheating Of Device | 2 |
Device Displays Incorrect Message | 2 |
Unintended System Motion | 2 |
Device Operates Differently Than Expected | 2 |
Electrical /Electronic Property Problem | 1 |
Inadequate Instructions For Healthcare Professional | 1 |
Insufficient Information | 1 |
Device Markings / Labelling Problem | 1 |
Incorrect Device Or Component Shipped | 1 |
| Total Device Problems | 46 |