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: 1
• Initial Importer: N
• 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 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 D080XXWAD985M16IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M16GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M16BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M15IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M15GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M15BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M14IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M14GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M14BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M12IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M12GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M12BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M10IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M10GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD985M10BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM25IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM25GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM25BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM22IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM22GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM22BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM20IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM20GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM20BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM18IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM18GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM18BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM16IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM16GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM16BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM15IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM15GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM15BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM14IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM14GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM14BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM12IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM12GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD95MM12BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD101M20IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD101M20GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD101M20BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD101M13IVO0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD101M13GRE0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXWAD101M13BLU0 YAMAHACHI DENTAL MFG.,CO.	WAX DISK	2023-10-13
GUDID D080XXRFBX17LXXXXX0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXD40 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXD30 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXD20 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXC40 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXC30 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXC20 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXC10 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXB40 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXB30 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXB20 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXB10 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXA40 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXA30 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXA20 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXXA10 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXW050 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXVPN0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXPNK0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXOPN0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXMBP0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXMBH0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXLFP0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
GUDID D080XXRFB2526XXLFA0 YAMAHACHI DENTAL MFG.,CO.	RE-FINE BRIGHT	2023-10-13
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

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