Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006942327

FEI Number

3006942327

Entity Name

Yamahachi Dental Material (Changshu) Co., Ltd.

City/State/Country

Changshu city Jiangsu, CN

Establishment Address

No. 8 Zhibei Road, Zhitang Town, Changshu city Jiangsu 215531, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Yamahachi Dental Mfg. Co. (Owner Number: 10024459)

Owner / Operator Contact Address

54-1Ochigara, Nishiura-Cho, Gamagori City, JP-23 443-0105, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K254091

PMA Number

N/A

All Registered Proprietary Names

Shade Guide Naperce Crown PX Soluut PX Efucera PX Efucera AC New Ace Flat AC BASIS FLOW II Weldenz TrinDy Surgical Guide Yamahachi Parafin Wax Bite Rim Sticks WAX DISK Crown NS Efucera NS Yamahachi Pink CAD/CAM Disk JUSTI PRODUCTS OEM DISK Basis Twin Cure Basis Hi Refine Bright Basis GLOSSY COAT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2008-02-03
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2024-03-06
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2013-03-02
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2026-04-23
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2016-06-27
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2016-03-17
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2018-04-30
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2013-08-08
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2026-04-07

Official Correspondent

Shuhei Hirota

US Agent Details

Lawrence Greenwald Business: Yamahachi Dental Products USA Email: Yamahachi1@yahoo.com Phone: (973) 3202909

Related Public Records

Same Entity

Yamahachi Dental Mfg. Co.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020841418	YAMAHACHI DENTAL MFG. CO.	Gamagori City Aichi, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K093019	Enamelite, LLC	ENAMELITE ACRYSEAL SPRAY SEALANT	2009-12-22

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 3006942327. Last updated year: 2026. Please use registration number 3006942327 when referencing this establishment in official correspondence.