Maruchi

FDA Filings

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

FDA Registration(s)
Registration Number3009560600
FEI Number3009560600
NameKevin Bang
Owner & OperatorMARUCHI
Contact Address2-208, Medical Industry Complex Bldg.,
Wonju-si KR-42 Gangweondo 26311 KR
Official Correspondent
  • Sung-wook Jang
  • 82-33-7340330-x
US Agent
Importing Logistics Registration
ImporterKB Dental products, Inc.
Address177 W. Orangthorpe Ave
Placentia, CA 92870 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address177 W.Orangethorpe Ave
Placentia, CA 92870 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Maruchi
CleaniCal2021-02-12
Kevin Bang [MARUCHI]
ENDOSONIC BLUE PORTABLE2019-05-16
Kevin Bang [MARUCHI]
ENDOSONIC BLUE KIT2019-05-16
MARUCHI
ENDOSEAL MTA2018-02-26
Kevin Bang [MARUCHI]
ENDOSEAL MTA2018-02-26
Kevin Bang [MARUCHI]
ENDOSEAL2015-12-23
Kevin Bang [MARUCHI]
ENDOCEM Zr2015-12-23
Kevin Bang [MARUCHI]
ENDOSONIC BLUE2015-12-21
Kevin Bang [MARUCHI]
ENDOSONIC BLUE PLUS2015-12-21
Kevin Bang [MARUCHI]
ENDOSONIC BLUE Ni-Ti File2015-12-21
Kevin Bang [MARUCHI]
ENDOSONIC BLUE Ni-Ti File 22015-12-21
MARUCHI
ENDOSEAL2014-05-12
MARUCHI
ENDOCEM ZR2014-05-12
Kevin Bang [MARUCHI]
ENDOCEM MTA2012-03-28
MARUCHI
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)2012-03-19

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