Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009795022

FEI Number

3009795022

Entity Name

SHIMMER COMPUTERIZED DENTAL TECHNOLOGY CO.,LTD

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

6th Floor, Building 1 (Plant 1#),, No. 350 Ziyuan West Road, Pingsha Town, Jinwan District, Zhuhai Guangdong 519060, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shimmer Computerized Dental Technology Co.,LTD (Owner Number: 10041865)

Owner / Operator Contact Address

6th Floor, Building 1 (Plant 1#),, No. 350 Zivuan, West Road, Pingsha Town, Jinwan District,, Zhuhai, CN-GD 519060, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dess Implant Dess Implant Shimmer Restoration, noble metal Dess Implant Shimmer Prosthesis, orthodontic Dess Implant Shimmer Restoration, resin, crown and bridge Shimmer Dentures, partial Dess Implant Shimmer Restoration, porcelain Dess Implant Shimmer Dentures, full Shimmer Restoration, porcelain-fused-to-metal Dess Implant Dess Implant Dess Implant

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	2025-07-02
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2025-07-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-02
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2012-09-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-02
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2012-09-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-09-13
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2012-09-12
NSK	Dentures, Partial	Unknown	Class N	N/A	2012-09-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-02
PNP	Dental Abutment Design Software For Dental Laboratory	Dental	Class 2	872.3630	2025-07-02
NSP	Restoration, Porcelain	Unknown	Class N	N/A	2012-09-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-09-13
NSL	Dentures, Full	Unknown	Class N	N/A	2012-09-12
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2012-09-12
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-02
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-07-02

Official Correspondent

shimmer Cai

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shimmer Computerized Dental 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

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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 3009795022. Last updated year: 2026. Please use registration number 3009795022 when referencing this establishment in official correspondence.