Instrument, Hand, Calculus Removal

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Jiangsu, Guangdong and Shandong, and 2 other provinces: 13 hold an FDA registration. 2 are contract manufacturers.

Coda Resources Ltd., Heze China Shandong, contract manufacturer
Guangdong Okay Technology Co., Ltd. Guangdong
Lakong Medical Devices Co., Ltd. Guangdong
Perfect Group Corp. Ltd. Jiangsu, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Shanghai Smedent Medical Instrument Co., Ltd. Shanghai
Shenzhen Samo Technology Co., Limited Guangdong
Shurcon Manufacturing Company Zhejiang
Taizhoufupaixinxikejiyouxiangongsi Zhejiang
Weihai Jieshi Commodity Manufacture Co., Ltd. Shandong
Wuxi Lyusmile IMP AND EXP Co., Ltd. Jiangsu
Zogear Medical Co., Ltd. Jiangsu, contract manufacturer
Zumax Medical Co., Ltd. Jiangsu, contract manufacturer

How Is ELA Classified?

Instrument, Hand, Calculus Removal is FDA product code ELA, Class 1, 21 CFR 872.4565.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

Instrument, Hand, Calculus Removal

Which Manufacturers in China Make This?

How Is ELA Classified?

How Does It Reach the US Market?

Where China Actually Supplies