Data / Medical devices / China / Sincera Technology (changchun) Co., Ltd
Sincera Technology (changchun) Co., Ltd: FDA-registered device maker in Changchun City Jilin, China, 2 510(k) clearances
Sincera Technology (changchun) Co., Ltd is registered with the FDA (registration 3038295269) in Changchun City Jilin, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038295269
- Address
- 2nd Floor, Building C, No. 5188 Guigu Street, Hi-tech District, Changchun City Jilin, China, 130012
- Owner or operator
- Sincera Technology (changchun) Co., Ltd (10093240)
- Roles
- Manufacturer
- First device listed
- April 17, 2025
- Registered through
- 2026
- Brand names listed
- Light Cure Adhesive, Light Cure Composite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 16, 2024 | K241056 | Light Cure Adhesive | KLE | Substantially Equivalent | Sincera Technology (Changchun) Co., Ltd. | accessdata.fda.gov |
| March 15, 2024 | K240112 | Light Cure Composite | EBF | Substantially Equivalent | Sincera Technology (Changchun) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.