Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012205930

FEI Number

3012205930

Entity Name

ZHUHAI CRYSTAL DENTAL TECHNOLOGY CO.,LTD

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

3F, extension building, No.6 Ivyuan Rd, Nanping Science and Technology Industrial Park, Zhuhai Guangdong 519000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zhuhai Crystal Dental Technology Co.,Ltd (Owner Number: 10050220)

Owner / Operator Contact Address

3F, extension building, No.6 Ivyuan Rd, Nanping Science and Technology Industrial Park, Zhuhai, CN-GD 519000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ZHUHAI CRYSTAL DENTAL TECHNOLOGY CO. ,LTD PERIO TRAY ZHUHAI CRYSTAL DENTAL TECHNOLOGY CO. ,LTD ZHUHAI CRYSTAL DENTAL TECHNOLOGY CO. ,LTD FGC Crown and Bridge ZHUHAI CRYSTAL DENTAL TECHNOLOGY CO. ,LTD ZHUHAI CRYSTAL DENTAL TECHNOLOGY CO. ,LTD Orthodontic Prosthesis ZHUHAI CRYSTAL DENTAL TECHNOLOGY CO. ,LTD

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	2026-03-13
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2015-10-22
KMT	Tray, Fluoride, Disposable	Dental	Class 1	872.6870	2022-08-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-03-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-03-13
NSO	Restoration, Porcelain-Fused-To-Metal	Unknown	Class N	N/A	2015-10-22
NSJ	Restoration, Noble Metal	Unknown	Class N	N/A	2021-11-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-03-13
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-03-13
NSR	Prosthesis, Orthodontic	Unknown	Class N	N/A	2021-11-24
NSL	Dentures, Full	Unknown	Class N	N/A	2015-10-22
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2026-03-13

Official Correspondent

Kevin Ke

US Agent Details

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

Related Public Records

Same Entity

Zhuhai Crystal 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 3012205930. Last updated year: 2026. Please use registration number 3012205930 when referencing this establishment in official correspondence.