Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015674635

FEI Number

3015674635

Entity Name

GUANGZHOU HEYGEARS IMC.INC

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Block B2, 501, 601, Enterprise Accelerator, Kaifa District, Guangzhou Guangdong 510700, CN

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K253798

PMA Number

N/A

All Registered Proprietary Names

UltraPrint-Dental Surgical Guide UV UltraPrint Surgical Guide UV UltraPrint Denture UV UltraPrint-Dental Denture UV UltraPrint On-X Teeth Try-in UV UltraPrint Hard Splint Try-in UV UltraPrint Flexible Try-in UV UltraPrint-Dental Denture Try-in UV UltraPrint Bleach Veil UV UltraPrint -Dental Tough Teeth For Try-in UV UltraPrint-Dental Try-in UV UltraPrint Try-in UV UltraPrint-Dental Flexible Try-in UV UltraPrint Tough Teeth For Try-in UV UltraPrint-Dental On-X Teeth Try-in UV UltraPrint-Dental Hard Splint Try-in UV UltraPrint-Dental Cast UV UltraPrint Cast UV UltraPrint-Dental Gingiva UV UltraPrint Gingiva UV UltraPrint Hard Splint UV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2019-10-13
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2025-12-05
EEA	Plate, Base, Shellac	Dental	Class 1	872.6200	2020-05-13
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2021-08-02
NOK	Material, External Aesthetic Restoration, No Adhesive	General, Plastic Surgery	Class 1	878.3800	2019-10-13
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2026-03-23
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2026-03-23

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
3021381014	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 3015674635. Last updated year: 2026. Please use registration number 3015674635 when referencing this establishment in official correspondence.