Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021381014

FEI Number

3021381014

Entity Name

GUANGZHOU HEYGEARS IMC.INC

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room 201-1, No.25, Yayingshi Road, Huangpu District, Guangzhou Guangdong 510700, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUANGZHOU HEYGEARS IMC.INC (Owner Number: 10061379)

Owner / Operator Contact Address

BLOCK B2,501,601,ENTERPRISE ACCELERATOR,KAIFA DISTRICT, Guangzhou, CN-GD 510700, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213643

PMA Number

N/A

All Registered Proprietary Names

UltraPrint-Dental IBT UV UltraPrint-Dental Model WW UV UltraPrint-Dental Model TF UV UltraPrint-Dental Tray UV UltraPrint-Dental Model HP UV UltraPrint-Dental Study Model UV UltraPrint-Dental Model E UV UltraPrint-Dental Model ES UV UltraPrint-Dental Model HS UV UltraPrint-Dental Model WW UltraPrint-Dental Model M UltraPrint-Dental Model GP UltraPrint-Dental Model M UV UltraPrint Tray UV UltraPrint Denture UV UltraPrint-Dental Denture UV UltraPrint-Dental Surgical Guide UV UltraPrint Surgical Guide UV UltraPrint-Dental Cast UV UltraPrint Cast UV UltraPrint Hard Splint UV UltraPrint Temp C&B UV UltraPrint-Dental Temp C&B UV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2019-10-13
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2025-12-05
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2019-10-13
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2021-08-02
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2026-03-23
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2026-03-23
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2022-01-16

Official Correspondent

Peiyan Gui

US Agent Details

Roger Wu Email: rogerwu@heygears.com Phone: (949) 4189418

Related Public Records

Same Entity

GUANGZHOU HEYGEARS IMC.INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015674635	GUANGZHOU HEYGEARS IMC.INC	Guangzhou Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19

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 3021381014. Last updated year: 2026. Please use registration number 3021381014 when referencing this establishment in official correspondence.