Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011713204

FEI Number

3011713204

Entity Name

Henan Lusterdent Medical Instrument Co.,Ltd

City/State/Country

Zhengzhou Henan, CN

Establishment Address

No. 101, 27th Floor, Unit 1 of Building 33, No. 21 of Yuegui Road, High-tech Industrial Development Zone,, Zhengzhou Henan 450000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Henan Lusterdent Medical Instrument Co.,Ltd (Owner Number: 10049376)

Owner / Operator Contact Address

No. 101, 27th Floor, Unit 1 of Building 33, No. 21 of Yuegui Road, High-tech Industrial Development Zone,, Zhengzhou, CN-HA 450000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Root Canal Post; Screw Post / Quartz Fiber Post Dental Contra Angle Handpiece / Dental Straight Handpiece Air Water Syringe Handpiece Unit / High Speed Dental Handpiece / Low Speed Dental Handpiece / Endodontic Barbed Broaches Endodontic Enlarger Drills/ Gates Drills / Dental Post Drills / Peeso Reamers / Fiber Post Drills Endo Motor / Rotary Motor / Endodontic Apex Locator. Prophy Brushes and Cups Articulating Paper Gutta Percha Point Micro Brush Applicator Absorbent Paper Points Abrasive Diamond Strips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELR	Post, Root Canal	Dental	Class 1	872.3810	2015-05-20
OFX	General Purpose Dental Tray	Dental	Class 1	872.6640	2015-05-20
EKW	Broach, Endodontic	Dental	Class 1	872.4565	2015-05-20
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2024-11-18
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2024-11-27
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2015-05-20
EFH	Paper, Articulation	Dental	Class 1	872.6140	2015-05-20
EKM	Gutta-Percha	Dental	Class 1	872.3850	2024-11-18
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2024-11-18
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2024-11-18
EHL	Point, Abrasive	Dental	Class 1	872.6010	2015-05-20

Official Correspondent

Qingmei Zhang

US Agent Details

Kai Li Email: likai323@hotmail.com Phone: (501) 7778490

Related Public Records

Same Entity

Henan Lusterdent Medical Instrument Co.,Ltd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011713204. Last updated year: 2026. Please use registration number 3011713204 when referencing this establishment in official correspondence.