| Device Type ID | 1165 |
| Device Name | Handpiece, Contra- And Right-angle Attachment, Dental |
| 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 | EGS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1165 |
| Device | Handpiece, Contra- And Right-angle Attachment, Dental |
| Product Code | EGS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Handpiece And Accessories. |
| CFR Regulation Number | 872.4200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BHT HYGIENETECHNIK GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTSPLY SIRONA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DIRECTA AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HANDPIECE HEADQUARTERS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SAESHIN PRECISION CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Overheating Of Device | 559 |
Temperature Problem | 117 |
Detachment Of Device Component | 92 |
Insufficient Information | 36 |
Dent In Material | 34 |
Mechanical Problem | 32 |
Detachment Of Device Or Device Component | 24 |
Failure To Service | 22 |
Physical Property Issue | 13 |
Device Maintenance Issue | 10 |
Handpiece | 9 |
Device Handling Problem | 6 |
Component Falling | 6 |
Improper Or Incorrect Procedure Or Method | 5 |
Cap | 4 |
Physical Resistance / Sticking | 4 |
Device Operates Differently Than Expected | 3 |
Corroded | 2 |
Maintenance Does Not Comply To Manufacturers Recommendations | 2 |
Bearings | 2 |
Use Of Device Problem | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Material Deformation | 2 |
Device Damaged By Another Device | 2 |
Expulsion | 1 |
Human Factors Issue | 1 |
Device Issue | 1 |
Sticking | 1 |
Malposition Of Device | 1 |
Break | 1 |
Component Missing | 1 |
Device Dislodged Or Dislocated | 1 |
Disassembly | 1 |
Retraction Problem | 1 |
Screw | 1 |
Fracture | 1 |
| Total Device Problems | 1002 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bien Air Dental SA | II | Sep-21-2015 |