Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009687180

FEI Number

3009687180

Entity Name

KTJ DENTAL LAB COMPANY LIMITED

City/State/Country

KL, HK

Establishment Address

FLAT/RM 705 7/F OFFICEPLUS @PRINCE EDWAR 794-802 NATHAN ROAD KL, KL 999077, HK

Establishment Type(s)

Foreign Private Label Distributor

Owner / Operator

KTJ DENTAL LAB COMPANY LIMITED (Owner Number: 10084369)

Owner / Operator Contact Address

FLAT/RM 705 7/F OFFICEPLUS @PRINCE EDWAR 794-802 NATHAN ROAD KL, KL, HK-NOTA 999077, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RETAINER, SCREW EXPANSION, ORTHODONTIC Abutment, Implant, Dental, Endosseous Metal Restoration (Noble Metal / Semi Precious Metal/ Base Metal) Abutment, Implant, Dental, Endosseous Dess Dental Smart Solution Dess Dental Smart Solution FLEXIBLE DENTURE; PARTIAL DENTURE; REMOVABLE PARTIAL DENTURE EMAX Crown / Bridge; Full Ceramic Restoration; Porcelain Restoration; Zirconia Crown / Bridge Mouthguard; Nightguard; Orthodontic Appliance; Retainer; Screw Appliance Surgical Guide Porcelain Fused to Metal Restoration Metal Restoration (Noble Metal/ Semi Precious Metal / Base Metal) COMPOSITE RESIN CROWN AND BRIDGE; TEMPORARY CROWN AND BRIDGE Dess Dental Smart Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2022-02-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-02-14
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2022-02-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-02-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-02-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-02-14
NSK	Dentures, Partial	Unknown	Class N	N/A	2022-02-14
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2022-02-14
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2022-02-14
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2022-02-14
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2022-02-14
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2022-02-14
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2022-02-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-02-14

Official Correspondent

Julia Yang

US Agent Details

Mike Ryan Business: Simply Shipped, LLC Email: simplyshipped.agent@gmail.com Phone: (414) 3264114

Related Public Records

Same Entity

KTJ DENTAL LAB COMPANY LIMITED

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.
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009687180. Last updated year: 2026. Please use registration number 3009687180 when referencing this establishment in official correspondence.