The following data is part of a premarket notification filed by Foshan Wenjian Medical Instrument Co., Ltd. with the FDA for High-speed Air Turbine Handpiece / Low-speed Air Turbine Handpiece.
| Device ID | K181691 |
| 510k Number | K181691 |
| Device Name: | High-speed Air Turbine Handpiece / Low-speed Air Turbine Handpiece |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | Foshan Wenjian Medical Instrument Co., Ltd. Third Floor, No. 3, Jiebian Industrial Zone, LuoCun Shishan Town, Nanhai Foshan, CN 528225 |
| Contact | Wen Huang |
| 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 | 2018-06-27 |
| Decision Date | 2020-05-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D884MAS0 | K181691 | 000 |
| D884FFBYHEAD1 | K181691 | 000 |
| D884FL68HEAD1 | K181691 | 000 |
| D884FL80HEAD1 | K181691 | 000 |
| D884F160 | K181691 | 000 |
| D884F415 | K181691 | 000 |
| D884F416 | K181691 | 000 |
| D884QC170 | K181691 | 000 |
| 16972249850214 | K181691 | 000 |
| D884FFBHEAD1 | K181691 | 000 |
| D884F541CA1 | K181691 | 000 |
| D884QC165K1 | K181691 | 000 |
| D884F411CA1 | K181691 | 000 |
| D884F416BM1 | K181691 | 000 |
| D884F424BM1 | K181691 | 000 |
| D884F424BSU1 | K181691 | 000 |
| D884F424BW1 | K181691 | 000 |
| D884F424BZ1 | K181691 | 000 |
| D884F434BSUW1 | K181691 | 000 |
| 16972249850221 | K181691 | 000 |
| 16972249850238 | K181691 | 000 |
| 16972249850368 | K181691 | 000 |
| 16972249850375 | K181691 | 000 |
| 16972249850382 | K181691 | 000 |
| D884AF450 | K181691 | 000 |
| D884AF90S0 | K181691 | 000 |
| D884AFT450 | K181691 | 000 |
| D884AFT900 | K181691 | 000 |
| D884FST0 | K181691 | 000 |
| 16972249850337 | K181691 | 000 |
| 16972249850320 | K181691 | 000 |
| 16972249850245 | K181691 | 000 |
| 16972249850252 | K181691 | 000 |
| 16972249850269 | K181691 | 000 |
| 16972249850276 | K181691 | 000 |
| 16972249850283 | K181691 | 000 |
| 16972249850290 | K181691 | 000 |
| 16972249850306 | K181691 | 000 |
| 16972249850313 | K181691 | 000 |
| D884QC164K1 | K181691 | 000 |