The following data is part of a premarket notification filed by Guangdong Jinme Medical Technology Co., Ltd. with the FDA for Dental Low-speed Turbine Handpiece.
| Device ID | K170236 |
| 510k Number | K170236 |
| Device Name: | Dental Low-speed Turbine Handpiece |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | Guangdong JINME Medical Technology Co., Ltd. A15, New Light Source Industrial Base, Nanhai District Foshan, CN 528000 |
| Contact | Kristi Yang |
| Correspondent | Cecilia Ceng Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou S Guangzhou, CN 510663 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-25 |
| Decision Date | 2017-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971119540029 | K170236 | 000 |