Yamahachi Dental Material Changshu Co L T D

FDA Filings

This page includes the latest FDA filings for Yamahachi Dental Material Changshu Co L T D. 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
PMN K172683 | EBI Yamahachi Dental Material (Changshu) Co., Ltd. [Yamahachi Dental Mfg. Co.]	Yamahachi Pink CAD/CAM Disk	2018-04-30
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