Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009482100

FEI Number

3009482100

Entity Name

KTJ Medical Technology Co.,Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

11A, Building 1, Kangtaijian Health Industry Building, No. 7, Rongtian Road,Jinsha Community, Kengzi, Pingshan area, Shenzhen Guangdong 518122, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

KTJ Medical Technology Co.,Ltd. (Owner Number: 10042301)

Owner / Operator Contact Address

11A, Building 1, Kangtaijian Health Industry Building, 7, Rongtian Road,Jinsha Community, Kengzi, Pingshan area, Shenzhen, CN-GD 518122, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dess Dental Smart Solution Dess Dental Smart Solution Metal Restoration (Noble Metal / Semi Precious Metal/ Base Metal) Partial Denture Flexible Denture Removable Partial Denture Dess Dental Smart Solution Dess Dental Smart Solution Dess Dental Smart Solution Metal Restoration (Base Metal) Dess Dental Smart Solution Immediate Denture Full Denture Coverdenture Denture Overdenture Denture Acrylic Denture Composite Resin Crown and Bridge Temporary Crown and Bridge Retainer, Screw Expansion, Orthodontic Dess Dental Smart Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-03
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2012-11-09
NSK	Dentures, Partial	Unknown	Class N	N/A	2012-11-09
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-10-16
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-10-16
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2025-08-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-03
NSL	Dentures, Full	Unknown	Class N	N/A	2012-11-09
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2025-08-05
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2025-08-05
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-03

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

KTJ Medical Technology 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
K211871	Faico Medical, LLC	FAICO Dental Implant System and CAD/CAM Abutments	2021-11-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2018	Implant Direct Sybron Manufacturing, LLC	2	Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

Similar Registrations

Registration Number	Establishment Name	Location
3013578168	DDS CARIBBEAN CORP	Guaynabo, PR, US
3030690317	TRATE LLC	Tamarac, FL, US
3011587077	JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.	Changzhou Jiangsu, CN
3012121192	DENTAL EVOLUTIONS, INC	Beverly Hills, CA, US
3031529635	TRATE UAB	Kaunas Kauno Apskritis, LT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009482100. Last updated year: 2026. Please use registration number 3009482100 when referencing this establishment in official correspondence.