The following data is part of a premarket notification filed by Changzhou Sifary Medical Technology Co., Ltd. with the FDA for Curingpen Dental Curing Light.
| Device ID | K221152 |
| 510k Number | K221152 |
| Device Name: | CuringPen Dental Curing Light |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | Changzhou Sifary Medical Technology Co., Ltd. No. 99, Qingyang Road, Xuejia County, Xinbei District Changzhou, CN 213000 |
| Contact | Iris Cai |
| Correspondent | Jie (Amanda) Zhu Changzhou Sifary Medical Technology Co., Ltd No. 99, Qingyang Road, Xuejia County, Xinbei District Changzhou City, CN 213000 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-20 |
| Decision Date | 2022-11-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972597781782 | K221152 | 000 |