Sincera Technology (Changchun) Co., Ltd.
ChinaFDA applicant, unverified FDA
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Sincera Technology (Changchun) Co., Ltd. makes
Sincera Technology (Changchun) Co., Ltd. manufactures dental composite resin products, including light-cure adhesives and light-cure composites designed for dental restorations.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) and UDI registries. The company is based in the US.
Catalogue
- Registry: GUDID
- Registry: GUDID
Light Cure Adhesive Ref K241056
Regimes: 510(k) Registry: 510(k)Light Cure Composite Ref K240112
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 728113467
FDA establishments
- Sincera Technology (Changchun) Co., Ltd Changchun City Jilin · CN FEI 3038295269
Frequently asked questions
How many devices does Sincera Technology (Changchun) Co., Ltd. have in the registry?
The registry currently lists 4 devices for Sincera Technology (Changchun) Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sincera Technology (Changchun) Co., Ltd.'s devices?
Among its 4 most recently registered devices, Sincera Technology (Changchun) Co., Ltd. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sincera Technology (Changchun) Co., Ltd.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Sincera Technology (Changchun) Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sincera Technology (Changchun) Co., Ltd. in the registry?
The most recently registered devices listed for Sincera Technology (Changchun) Co., Ltd. include SINCERA A1 4g/syringe, SINCERA 3ml, Light Cure Adhesive and Light Cure Composite.
Which FDA establishments are linked to Sincera Technology (Changchun) Co., Ltd.?
1 FDA establishment is linked to Sincera Technology (Changchun) Co., Ltd. in the registry; they are listed on the company page.