| Device Type ID | 1103 |
| Device Name | Drill, Bone, Powered |
| 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 | DZI |
| 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 | 1103 |
| Device | Drill, Bone, Powered |
| Product Code | DZI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Cutting Instrument And Accessories. |
| CFR Regulation Number | 872.4120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DONG IL TECHNOLOGY LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MECTRON SPA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PM-PRIVATSTIFTUNG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAESHIN PRECISION CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SATELEC-ACTEON GROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 114 |
Device Markings / Labelling Problem | 12 |
Material Fragmentation | 10 |
Overheating Of Device | 7 |
Material Twisted / Bent | 7 |
Device-Device Incompatibility | 5 |
Device Stops Intermittently | 3 |
Use Of Device Problem | 2 |
Detachment Of Device Or Device Component | 2 |
Packaging Problem | 2 |
Device Or Device Fragments Location Unknown | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Thermal Decomposition Of Device | 1 |
Entrapment Of Device | 1 |
Dull, Blunt | 1 |
Material Deformation | 1 |
Unintended Movement | 1 |
Peeled / Delaminated | 1 |
Fitting Problem | 1 |
Component Missing | 1 |
Failure To Cut | 1 |
Missing Information | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 177 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nobel Biocare Usa Llc | II | Aug-09-2016 |