Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008799812

FEI Number

3008799812

Entity Name

COSMETIC INTERNATIONAL LIMITED

City/State/Country

Kowloon Bay KL, HK

Establishment Address

Unit 2105, 21/F, Exchange Tower 33, Wang Chiu Rd, Kowloon Bay KL 86, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Cosmetic International Limited (Owner Number: 10035050)

Owner / Operator Contact Address

Unit 2105, 21/F, Exchange Tower 33, Wang Chiu Rd, Kowloon Bay KL, HK-NOTA 852, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cosmetic Restoration, Resin, Crown and Bridge Cosmetic Restoration, Porcelain-Fused-To-Metal Cosmetic Dentures, Partial Cosmetic Restoration, Base Metal Cosmetic Dentures, Full Cosmetic Restoration, Resin Cosmetic Restoration, Noble Metal Cosmetic Accessaries, Implant, Dental, Endosseous Cosmetic Prosthesis, Orthodontic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2018-03-19
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2018-03-19
NSK	Dentures, Partial	Unknown	Class N	N/A	2018-03-19
NSQ	Restoration, Base Metal	Unknown	Class N	N/A	2018-03-19
NSL	Dentures, Full	Unknown	Class N	N/A	2018-03-19
NSM	Restoration, Resin	Unknown	Class N	N/A	2018-03-19
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2018-03-19
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2011-01-28
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2018-03-19

Official Correspondent

Philip Wu

US Agent Details

Julie Wannemuehler Email: julie@mogo.com Phone: (630) 3236192

Related Public Records

Same Entity

Cosmetic 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.

Similar Registrations

Registration Number	Establishment Name	Location
3025358043	SHENZHEN ROBUST DENTAL LABORATORY CO., LIMITED	Shenzhen Guangdong, CN
3019793783	Aceso Dental Laboratory Company Limited	An Phuoc Ward Dong Nai, VN
3005126636	CORNERSTONE BIOCOMP ENTERPRISES INC	Bristol, PA, US
3013950969	Modern Dental Laboratory (DG) Co., Ltd.	Dongguan Guangdong, CN
3008155930	DAMORE DENTAL LAB LLC	Houtzdale, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008799812. Last updated year: 2026. Please use registration number 3008799812 when referencing this establishment in official correspondence.