SINO-DENTEX CO.,LTD

FDA Device Registration & Listing · Changchun Jilin, CN · Registration 3018283083

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018283083
FEI Number
3018283083
Entity Name
SINO-DENTEX CO.,LTD
City/State/Country
Changchun Jilin, CN
Establishment Address
721 Chenggong Road High-Tech Development District, Changchun Jilin 130000, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SINO-DENTEX CO.,LTD (Owner Number: 10083627)
Owner / Operator Contact Address
721 Chenggong Road High-Tech Development District, Changchun, CN-JL 130000, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K232978
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2023-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

Scott Yin Email: weilirui@gmail.com Phone: (847) 5255258

Related Public Records

Same Entity

SINO-DENTEX 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
K020499 Jeneric/Pentron, Inc. BOND-3 ADHESIVE 2002-04-22
K801093 Dentsply Intl. PRISMA-BOND 1980-05-20
K061981 Apex Dental Materials, Inc. SURPASS 2006-07-31
K110302 3M Espe AG ADHESIVE EXL-759 2011-05-19
K071131 3M Espe AG Dental Products UNO 2007-07-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018283083. Last updated year: 2026. Please use registration number 3018283083 when referencing this establishment in official correspondence.
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