Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020841418

FEI Number

3020841418

Entity Name

YAMAHACHI DENTAL MFG. CO.

City/State/Country

Gamagori City Aichi, JP

Establishment Address

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

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K131036

PMA Number

N/A

All Registered Proprietary Names

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2026-04-07
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2016-03-17
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2015-12-07
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2016-06-27
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2018-04-30
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
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2026-04-23
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2013-08-08

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
3006942327	Yamahachi Dental Material (Changshu) Co., Ltd.	Changshu city Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K093019	Enamelite, LLC	ENAMELITE ACRYSEAL SPRAY SEALANT	2009-12-22
K030585	Bisco, Inc.	SCULPTING RESIN	2003-04-28
K790438	Vivadent (Usa), Inc.	COLORANT	1979-04-10
K901050	Pulpdent Corp.	NO-STICK COMPOSITE INSTRUMENT DIP	1990-04-19
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11

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 3020841418. Last updated year: 2026. Please use registration number 3020841418 when referencing this establishment in official correspondence.