The following data is part of a premarket notification filed by Nanning Vv Dental Co., Ltd. with the FDA for Ultrasonic Scaler.
| Device ID | K163414 |
| 510k Number | K163414 |
| Device Name: | Ultrasonic Scaler |
| Classification | Scaler, Ultrasonic |
| Applicant | NANNING VV DENTAL CO., LTD. 4th Floor,North Bld. No.1 , Zhengxin Tech Zone, No. 2, Gaoxin 7 Rd. Nan Ning, CN 530007 |
| Contact | Liang Chaojun |
| Correspondent | Liang Chaojun NANNING VV DENTAL CO., LTD. 4th Floor,North Bld. No.1 , Zhengxin Tech Zone, No. 2, Gaoxin 7 Rd. Nan Ning, CN 530007 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-05 |
| Decision Date | 2017-11-21 |