| Device Type ID | 1287 |
| Device Name | Handpiece, Rotary Bone Cutting |
| 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 | KMW |
| 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 | 1287 |
| Device | Handpiece, Rotary Bone Cutting |
| Product Code | KMW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Bone Cutting Instrument And Accessories. |
| CFR Regulation Number | 872.4120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NAKANISHI INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSTEOMED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Temperature Problem | 22 |
Insufficient Information | 17 |
Overheating Of Device | 8 |
Maintenance Does Not Comply To Manufacturers Recommendations | 3 |
Physical Property Issue | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Device Operates Differently Than Expected | 2 |
Break | 2 |
Mechanical Problem | 2 |
Device Issue | 2 |
Device Maintenance Issue | 1 |
Handpiece | 1 |
Failure To Service | 1 |
Appropriate Term/Code Not Available | 1 |
Inadequate Instructions For Healthcare Professional | 1 |
| Total Device Problems | 67 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nakanishi Inc. | II | Oct-24-2018 |