Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3038295269

FEI Number

3038295269

Entity Name

SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD

City/State/Country

Changchun Jilin, CN

Establishment Address

No.177 Changda Rd, Hi-tech District, Changchun Jilin 130012, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sincera Technology (changchun) Co., Ltd (Owner Number: 10093240)

Owner / Operator Contact Address

No.177 Changda Rd, Hi-tech District, Changchun, CN-JL 130012, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240112

PMA Number

N/A

All Registered Proprietary Names

Light Cure Composite

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-04-17

Official Correspondent

Tony Su

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Sincera Technology (changchun) Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038295269. Last updated year: 2026. Please use registration number 3038295269 when referencing this establishment in official correspondence.