Qinhuangdao Audental Metal Technology Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3013546336
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Qinhuangdao Audental Metal Technology Co., Ltd. makes
The company manufactures dental zirconia materials, including unshaded and pre-shaded variants, used for dental restorations such as crowns, bridges, and inlays.
These products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3013546336
- Address
- Floor 2, 16 North D, 1 Yanghe Road, Development Area, Qinhuangdao City Hebei
Frequently asked questions
How many devices does Qinhuangdao Audental Metal Technology Co., Ltd. have in the registry?
The registry currently lists 1 device for Qinhuangdao Audental Metal Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qinhuangdao Audental Metal Technology Co., Ltd.'s devices?
Among its 1 most recently registered device, Qinhuangdao Audental Metal Technology Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Qinhuangdao Audental Metal Technology Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Qinhuangdao Audental Metal Technology Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Qinhuangdao Audental Metal Technology Co., Ltd. in the registry?
The most recently registered devices listed for Qinhuangdao Audental Metal Technology Co., Ltd. include Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia.