The following data is part of a premarket notification filed by Guangdong Jinme Medical Technology Co., Ltd. with the FDA for Dental High-speed Turbine Handpiece.
| Device ID | K170229 |
| 510k Number | K170229 |
| Device Name: | Dental High-speed Turbine Handpiece |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD. A15, NEW LIGHT SOURCE INDUSTRIL BASE NANHAI DISTRICT Foshan, CN 528000 |
| Contact | Kristi Yang |
| Correspondent | Cassie Lee GUANGZHOU GLOMED BIOLOGICAL TECHNOLOGY CO.,LTD SUITE 306, KECHENG MANSION, NO.121 SCIENCE ROAD, GUANGZHOU SCIENCE PARK 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 | 2017-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971119540012 | K170229 | 000 |