Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
ChinaFDA applicant, unverified
- Devices
- 27
What Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. makes
The company produces dental braces manufactured using 3D biologic printing technology, including models such as HK-Y-0.4, HK-Y-0.45, and variations up to HK-Y-2.0, designed for orthodontic applications.
These dental braces are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer operates from the United States.
Catalogue
Search and filter all 27 devicesCompany details
- DUNS number
- 410789418
Frequently asked questions
How many devices does Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. have in the registry?
The registry currently lists 27 devices for Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.'s devices?
Among its 27 most recently registered devices, Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (26 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.'s devices fall under?
Among its 27 most recently registered devices, the classes recorded for Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. in the registry?
The most recently registered devices listed for Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. include NA HK-Y-0.9, NA HK-Y-ST-0.76, NA HK-Y-0.7 and NA HK-Y-0.45.