The following data is part of a premarket notification filed by Foshan Cicada Dental Instrument Co., Ltd. with the FDA for Dental High Speed Handpiece, Dental Low Speed Handpiece.
| Device ID | K181900 |
| 510k Number | K181900 |
| Device Name: | Dental High Speed Handpiece, Dental Low Speed Handpiece |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | Foshan CICADA Dental Instrument Co., Ltd. B5-2F, Guangdong New Light Source Industrial Base Shihan, Nanhai District Foshan, CN 528247 |
| Contact | Juan Liu |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co, Lt Room 2012#, Gebu Commercial Building, Hongxing Community Songgang Baoan District Shenzhen, CN 518000 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-16 |
| Decision Date | 2019-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974456210105 | K181900 | 000 |
| 06974456210020 | K181900 | 000 |