Yamahachi Dental Mfg Co

FDA Filings

This page includes the latest FDA filings for Yamahachi Dental Mfg Co. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3006942327

FEI Number

3006942327

Name

Yamahachi Dental Material (Changshu) Co., Ltd.

Owner & Operator

Yamahachi Dental Mfg. Co.

Contact Address

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

Official Correspondent

Tomoki Sugiura
081-533-577121-x

US Agent

Lawrence Greenwald
Yamahachi Dental Products USA
973 3202909
973 3202995
Yamahachi1@yahoo.com

Importing Logistics Registration

Importer	Unix Japan Group
Address	1600 W. Redondo Beach Blvd Suite 401 Gardena, CA 90247 UNITED STATES
Email Address	toshiko@eureka-global.net
Phone	1 310 4356358
Importer Type	Retailer

Importing Logistics Registration

Importer	Yamahachi Dental Products USA Inc.
Address	160 Park Avenue Nutley, NJ 07110 UNITED STATES
Importer Type	Retailer

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

Zhi Tang
Changshu city Jiangsu, 215531 CN

Establishment Type

Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID D080XXPMD985M20W0M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20D4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20D3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20D2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20C4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20C3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20C2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20C1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20B4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20B3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20B2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20B1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20A4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15W0M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15D4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15D3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15D2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15C4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15C3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15C2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15C1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15B4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15B3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15B2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15B1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15A4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15A3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15A2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M15A1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M1535M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20W0M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20D4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20D3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20D2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20C4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20C3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20C2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20C1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20B4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20B3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20B2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20B1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20A4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20A3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20A2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM20A1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM2035M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15W0M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15D4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15D3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15D2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15C4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15C3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15C2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15C1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15B4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15B3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15B2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15B1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15A4M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15A3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15A2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM15A1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD95MM1535M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-20
GUDID D080XXPMD985M20A3M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-19
GUDID D080XXPMD985M20A2M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-19
GUDID D080XXPMD985M20A1M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-19
GUDID D080XXPMD985M2035M0 YAMAHACHI DENTAL MFG.,CO.	PMMA DISK	2024-09-19
GUDID D080XXBF220MLXXXXX0 YAMAHACHI DENTAL MFG.,CO.	BASIS FLOW II	2024-05-14
GUDID D080XXBF220MLXXOPN0 YAMAHACHI DENTAL MFG.,CO.	BASIS FLOW II	2024-04-05
GUDID D080XXBF2040GXXVPN0 YAMAHACHI DENTAL MFG.,CO.	BASIS FLOW II	2024-04-05
GUDID D080XXBF2040GXXOPN0 YAMAHACHI DENTAL MFG.,CO.	BASIS FLOW II	2024-04-05
GUDID D080XXBF2040GXXLFP0 YAMAHACHI DENTAL MFG.,CO.	BASIS FLOW II	2024-04-05
GUDID D080XXBF2040GXXLFA0 YAMAHACHI DENTAL MFG.,CO.	BASIS FLOW II	2024-04-05
GUDID D080XXBF2040GXXCLE0 YAMAHACHI DENTAL MFG.,CO.	BASIS FLOW II	2024-04-05
GUDID D080XXRFB2526XXCLP0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXCLE0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXA350 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB20MLXXXXX0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXD40 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXD30 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXD20 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXC40 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXC30 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXC20 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXC10 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXB40 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXB30 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXB20 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXXB10 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXW050 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXVPN0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXPNK0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXOPN0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXMBP0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXMBH0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXLFP0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXLFA0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXCLP0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB15G2XXCLE0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
PMN K172683 \| EBI Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Yamahachi Pink CAD/CAM Disk	2018-04-30
PMN K172683 Yamahachi Dental Mfg., Co.	Yamahachi Pink CAD/CAM Disk	2018-01-16
EGD Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Yamahachi Parafin Wax	2016-06-27
EGD Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Bite Rim Sticks	2016-06-27
ELM Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Crown NS Efucera NS	2016-03-17
PMN K151764 \| EBG Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Yamahachi PMMA Disks	2015-12-07
PMN K131036 \| EBI Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Refine Bright	2013-08-08
PMN K131036 \| EBI Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Basis	2013-08-08
PMN K131036 \| EBI Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Basis Twin Cure	2013-08-08
PMN K131036 \| EBI Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Basis Hi	2013-08-08
ELZ Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Weldenz	2013-03-10
EHP Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Weldenz	2013-03-10
PMN K111709 \| EBI Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Weldenz	2013-03-02
PMN K060507 \| ELM Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Soluut PX	2008-02-03
PMN K060507 \| ELM Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	New Ace	2008-02-03
PMN K060507 \| ELM Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Naperce	2008-02-03
PMN K060507 \| ELM Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Efucera PX	2008-02-03
PMN K060507 \| ELM Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Efucera AC	2008-02-03
PMN K060507 \| ELM Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Crown PX	2008-02-03

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090930391	Singapore,Singapore -> Tacoma, Washington	(16 CARTONS) DENTAL MATERIALS HS CODE 3006.4 II	1 PKG
2020080771978	Singapore,Singapore -> Tacoma, Washington	DENTAL MATERIALS HS CODE:3006.40, 4202.92	16 CTN
2019092521186	Nagoya Ko ,Japan -> Los Angeles, California	MODELLING PASTES, DENTAL WAX HS CODE: 3407.00 ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE: 2019/08/22	50 CTN
2019092521186	Nagoya Ko ,Japan -> Los Angeles, California	ESTERS OF METHACRYLIC ACID HS CODE: 2916.14 ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE: 2019/08/22	50 CTN
2019091252423	Nagoya Ko ,Japan -> Los Angeles, California	MODELLING PASTES, DENTAL WAX HS CODE: 3407.00 ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE: 2019/08/22	50 CTN
2019091252423	Nagoya Ko ,Japan -> Los Angeles, California	ESTERS OF METHACRYLIC ACID HS CODE: 2916.14 ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE: 2019/08/22	50 CTN
2019082229174	Nagoya Ko ,Japan -> Los Angeles, California	ESTERS OF METHACRYLIC ACID METHYL METHALCRYLATE,MONOMER,STABILIZED HS CODE 2916.14 ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE :2019/07/24	6 CTN
2019082229174	Nagoya Ko ,Japan -> Los Angeles, California	MODELLING PASTES,DENTAL WAX RESIN SOLUTION HS CODE 3407.00 ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE :2019/07/24	6 CTN
2019081558324	Nagoya Ko ,Japan -> Los Angeles, California	ESTERS OF METHACRYLIC ACID METHYL METHALCRYLATE,MONOMER,STABILIZED HS CODE 2916.14 ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE :2019/07/24	6 CTN
2019081558324	Nagoya Ko ,Japan -> Los Angeles, California	MODELLING PASTES,DENTAL WAX RESIN SOLUTION HS CODE 3407.00 ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE :2019/07/24	6 CTN
2019040455053	Nagoya Ko ,Japan -> Los Angeles, California	MODELLING PASTES, DENTAL WAX ACCEPTED BY: NAGOYA CUSTOMS APPROVAL DATE:2019/03/15	12 CTN
2019040455053	Nagoya Ko ,Japan -> Los Angeles, California	METHYL METHACRYLATE,MONOMER,STABILIZED ESTERS OF METHACRYLIC ACID HS CODE: 2916.14 ACCEPTED BY: NAGOYA CUSTOMS APPROVAL DATE: 2019/03/15	12 CTN
2019040455053	Nagoya Ko ,Japan -> Los Angeles, California	RESIN SOLUTION ESTERS OF METHACRYLIC ACID HS CODE: 2916.14 ACCEPTED BY: NAGOYA CUSTOMS APPROVAL DATE:2019/03/15	12 CTN
2018113058682	Nagoya Ko ,Japan -> Los Angeles, California	MODELLING PASTES, DENTAL WAX HS CODE : 3407.00 ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE :2018/11/12	30 CTN
2018113058682	Nagoya Ko ,Japan -> Los Angeles, California	ESTERS OF METHACRYLIC ACID HS CODE: 2916.14 MODELLING PASTES, DENTAL WAX HS CODE : 3407.00 METHYL METHACRYLATE,MONOMER,STABILIZED ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE : 2018/11/12	30 CTN
2018113058682	Nagoya Ko ,Japan -> Los Angeles, California	ESTERS OF METHACRYLIC ACID HS CODE : 2916.14 MODELLING PASTES, DENTAL WAX HS CODE : 3407.00 ACCEPTED BY NAGOYA CUSTOMS APPROVAL DATE : 2018/11/12	30 CTN