Biotem Co L T D

FDA Filings

This page includes the latest FDA filings for Biotem 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 Number3009611645
FEI Number3009611645
NameYONG K PARK
Owner & OperatorBiotem Co., Ltd.
Contact Address57, Sasang-ro , 401 Beon-gil , Sasang-gu
Busan KR-26 Busan Gwangyeogsi 46942 KR
Official Correspondent
  • Hong K Yeo
  • 82-70-8220493-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address212 WELLS AVE. S. 102
Renton, WA 98507 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Biotem Co., Ltd.
AR_N SLA Type Implant System2020-02-21
YONG K PARK [Biotem Co., Ltd.]
AR_N Type Implant System2018-03-19
YONG K PARK [Biotem Co., Ltd.]
AR_N Type Implant System2018-03-19
YONG K PARK [Biotem Co., Ltd.]
IR Type Implant System2018-03-19
YONG K PARK [Biotem Co., Ltd.]
IR Type Implant System2018-03-19
YONG K PARK [Biotem Co., Ltd.]
BR Type Implant System2018-03-19
YONG K PARK [Biotem Co., Ltd.]
BR Type Implant System2018-03-19
YONG K PARK [Biotem Co., Ltd.]
Torque Wrench2018-03-19
YONG K PARK [Biotem Co., Ltd.]
IR Solid Lab Analog2018-03-19
YONG K PARK [Biotem Co., Ltd.]
IR Pick-Up Impression Coping2018-03-19
YONG K PARK [Biotem Co., Ltd.]
IR Fixture Lab Analog2018-03-19
YONG K PARK [Biotem Co., Ltd.]
BR Transfer Impression Coping2018-03-19
YONG K PARK [Biotem Co., Ltd.]
BR Pick-Up Impression Coping2018-03-19
YONG K PARK [Biotem Co., Ltd.]
BR Lab Analog2018-03-19
YONG K PARK [Biotem Co., Ltd.]
BR Hand Driver2018-03-19
YONG K PARK [Biotem Co., Ltd.]
AR_N Transfer Impression Coping2018-03-19
YONG K PARK [Biotem Co., Ltd.]
AR_N Solid Lab Analog2018-03-19
YONG K PARK [Biotem Co., Ltd.]
AR_N Pick-Up Impression Coping2018-03-19
YONG K PARK [Biotem Co., Ltd.]
AR_N Hand Driver2018-03-19
YONG K PARK [Biotem Co., Ltd.]
AR_N Fixture Lab Analog2018-03-19
YONG K PARK [Biotem Co., Ltd.]
IR Fixture Driver for Wrench2018-03-19
YONG K PARK [Biotem Co., Ltd.]
IR Fixture Driver for Machine2018-03-19
YONG K PARK [Biotem Co., Ltd.]
BR Fixture Driver for Wrench2018-03-19
YONG K PARK [Biotem Co., Ltd.]
BR Fixture Driver for Machine2018-03-19
YONG K PARK [Biotem Co., Ltd.]
AR_N Fixture Driver for Wrench2018-03-19
YONG K PARK [Biotem Co., Ltd.]
AR_N Fixture Driver for Machine2018-03-19
YONG K PARK [Biotem Co., Ltd.]
Parallel Pin2018-03-19
YONG K PARK [Biotem Co., Ltd.]
Fixture Pin2018-03-19
YONG K PARK [Biotem Co., Ltd.]
Tapered Drill2018-03-19
YONG K PARK [Biotem Co., Ltd.]
Straight Drill2018-03-19
YONG K PARK [Biotem Co., Ltd.]
Point Drill2018-03-19
YONG K PARK [Biotem Co., Ltd.]
Marking Drill2018-03-19
YONG K PARK [Biotem Co., Ltd.]
Drill Extension2018-03-19
YONG K PARK [Biotem Co., Ltd.]
Cortical Drill2018-03-19
Biotem Co.,Ltd.
BR Type Implant System2018-02-09
Biotem Co., Ltd.
AR_N Type Implant System2018-01-31
Biotem Co., Ltd.
IR Type Implant System2017-12-01

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