| Device Classification Name |
Handpiece, Air-Powered, Dental
|
|---|
| 510(k) Number |
K241074 |
|---|
| Device Name |
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) |
|---|
| Applicant |
| Foshan Soco Precision Instrument Co., Ltd. |
| 3-5 Floor Bldg. 4, District A And 5 Floor Bldg. 3, District |
| Guangdong New Light Source Industrial Base, Luocun, Shishan |
|
Foshan,
CN
528226
|
|
| Applicant Contact |
Gou Xiao |
| Correspondent |
| Beijing Believe-Med Technology Service Co., Ltd. |
| Rm.912, Bldg. #15, Xiyuehui, #5 |
| Yihe N. Rd., Fangshan District |
|
Beijing,
CN
102401
|
|
| Correspondent Contact |
Ray Wang |
| Regulation Number | 872.4200 |
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 04/19/2024 |
|---|
| Decision Date | 11/12/2024 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Dental
|
|---|
| 510k Review Panel |
Dental
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|
|
|
