| Device Type ID | 1148 |
| Device Name | Handpiece, Air-powered, 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 | EFB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1148 |
| Device | Handpiece, Air-powered, Dental |
| Product Code | EFB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Dental Handpiece And Accessories. |
| CFR Regulation Number | 872.4200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CODENT TECHNICAL INDUSTRY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
DENTAL SAVINGS CLUB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTALEZ, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DENTSPLY SIRONA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
HANDPIECE CLUB, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HANDPIECE HEADQUARTERS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KAVO DO BRASIL INDUSTRIA E COMERCIO LTDA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LARES RESEARCH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRON CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MODERN KOREA CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NAKANISHI, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PM-PRIVATSTIFTUNG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
PREMIUM PLUS INTERNATIONAL LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TTBIO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Overheating Of Device | 261 |
Detachment Of Device Component | 54 |
Detachment Of Device Or Device Component | 27 |
Mechanical Problem | 18 |
Material Separation | 13 |
Use Of Device Problem | 10 |
Device Maintenance Issue | 9 |
Dent In Material | 8 |
Improper Or Incorrect Procedure Or Method | 8 |
Maintenance Does Not Comply To Manufacturers Recommendations | 7 |
Device Handling Problem | 6 |
Failure To Service | 4 |
Break | 3 |
Misassembly By Users | 2 |
Migration Or Expulsion Of Device | 2 |
Device Operates Differently Than Expected | 2 |
Physical Property Issue | 2 |
Device Dislodged Or Dislocated | 2 |
Screw | 1 |
Unintended Ejection | 1 |
Appropriate Term/Code Not Available | 1 |
Inadequate Service | 1 |
Decoupling | 1 |
Misconnection | 1 |
Device Issue | 1 |
Installation-Related Problem | 1 |
Air Leak | 1 |
Use Of Incorrect Control Settings | 1 |
Fail-Safe Design Failure | 1 |
Leak / Splash | 1 |
Lack Of Maintenance Documentation Or Guidelines | 1 |
Temperature Problem | 1 |
Insufficient Information | 1 |
Component Falling | 1 |
| Total Device Problems | 454 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | MTI Precision Products LLC. | II | Jul-12-2014 |
| 2 | Nakanishi Inc. | II | Aug-26-2016 |