Mouthguard, Over-The-Counter
Which Manufacturers in China Make This?
4 manufacturers in China hold an FDA registration for this device type, concentrated in Fujian, Jiangsu and Shandong.
- Fuzhou Delphin BIO-Tech Co., Ltd. Fujian
- Hynaut Health Technology Co., Ltd. Shandong, contract manufacturer
- Ranir Changshu Oral Care Co., Ltd. Jiangsu
- Xiamen Yizhou IMP. & EXP. Co., Ltd. Fujian, contract manufacturer
What Is This Device?
To protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
How Is OBR Classified?
Mouthguard, Over-The-Counter is FDA product code OBR, unclassified.
What Does It Take to Sell It in the United States?
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 1 clearance under this code; the FDA took 60 days from receipt to decision.
Name
Record