SKY HKMC INTERNATIONAL LIMITED

FDA Device Registration & Listing · HONG KONG, HK · Registration 3038290056

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
3038290056
FEI Number
3038290056
Entity Name
SKY HKMC INTERNATIONAL LIMITED
City/State/Country
HONG KONG, HK
Establishment Address
UNIT A 17/F ETON BLDG 288 DESVOEUX RD CENTRAL, HONG KONG 999077, HK
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
SKY HKMC INTERNATIONAL LIMITED (Owner Number: 10093299)
Owner / Operator Contact Address
UNIT A 17/F ETON BLDG 288 DESVOEUX RD CENTRAL, HONG KONG, HK-NOTA 999077, HK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Restomtian,resin Aocessongs implant dentat, andosscous Restoralion noole metal Heslpration, porcelaln Dentures,Partial-Dentures,Partial

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NSM Restoration, Resin Unknown Class N N/A 2025-04-30
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2025-04-30
NSJ Restoration, Noble Metal Unknown Class N N/A 2025-04-30
NSP Restoration, Porcelain Unknown Class N N/A 2025-04-30
NSK Dentures, Partial Unknown Class N N/A 2025-04-26

Official Correspondent

Zhengyan Chen

US Agent Details

Gene Xiao Email: Genexiao.sky@gmail.com Phone: (512) 6892744

Related Public Records

Same Entity

SKY HKMC INTERNATIONAL LIMITED
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038290056. Last updated year: 2026. Please use registration number 3038290056 when referencing this establishment in official correspondence.
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