The following data is part of a premarket notification filed by Foshan Cicada Dental Instrument Co., Ltd. with the FDA for Led Curing Light.
| Device ID | K192233 |
| 510k Number | K192233 |
| Device Name: | LED Curing Light |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | Foshan CICADA Dental Instrument Co., Ltd. B5-2F, Guangdong New Light Source Industrial Base Shihan Town, Nanhai Foshan, CN |
| Contact | Juan Liu |
| Correspondent | Jet Li KEDA Biological Technology Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2020-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974456210006 | K192233 | 000 |
| 06974456210044 | K192233 | 000 |
| 06974456210037 | K192233 | 000 |
| 06974456210983 | K192233 | 000 |