Manufacturer registered with FDA

Sincera Technology (changchun) Co., Ltd

Changchun City, China. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10093240Manufacturer2 clearances in five years

Device types listed: 2
Brands and models: 2
510(k) clearances: 22024–2024
Markets registered in: 1United States
Establishments: 1China

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Sincera Technology (changchun) Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	Light Cure Composite	2025
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	Light Cure Adhesive	2025

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Sincera Technology (changchun) Co., Ltd as the applicant.

Decided	510(k)	Device	Device type
16 Jul 2024	K241056	Light Cure Adhesive	KLE Resin Tooth Bonding Agent
15 Mar 2024	K240112	Light Cure Composite	EBF Resin Tooth Shade Material

Registered establishments

Establishment	Location	What it does
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTDFDA reg. 3038295269	Changchun City Jilin, China	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10093240). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.