Locator, Root Apex
Which Manufacturers in China Make This?
8 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Jiangsu and Guangxi, and 1 other province.
- Changzhou Bomedent Medical Technology Co., Ltd. Jiangsu, contract manufacturer
- Changzhou Sifary Medical Technology Co., Ltd. Jiangsu
- Denjoy Dental Co., Ltd. Hunan, contract manufacturer
- Foshan Coxo Medical Instrument Co., Ltd. Guangdong
- Guilin Woodpecker Medical Instrument Co., Ltd. Guangxi
- Shenzhen Perfect Medical Instruments Co., Ltd. Guangdong
- Shenzhen Rogin Medical Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Superline Technology Co., Ltd. Guangdong, contract manufacturer
How Is LQY Classified?
Locator, Root Apex is FDA product code LQY, unclassified.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 7 clearances under this code; the FDA took a median of 207 days from receipt to decision on them.
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