Acrodent Co L T D

FDA Filings

This page includes the latest FDA filings for Acrodent 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 Number3010232540
FEI Number3010232540
NameJun Song
Owner & OperatorACRODENT Co., Ltd.
Contact Address(Heung-dong), 5, Jeonha-ro85beon-gil
Gimhae KR-48 Gyeongsangnamdo 621-120 KR
Official Correspondent
  • Sang Hoon Lee
  • 82-55-3144607-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4601 BELL BLVD
Bayside, NY 11361 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Jun Song [ACRODENT Co., Ltd.]
TORQUE WRENCH (HAND TYPE)2018-12-03
Jun Song [ACRODENT Co., Ltd.]
THE SIMPLE PROSTHETIC KIT; PROSTHETIC KIT; PROSTHETIC2018-12-03
Jun Song [ACRODENT Co., Ltd.]
THE SIMPLE INSTALL KIT; INSTALL KIT; INSTALL2018-12-03
Jun Song [ACRODENT Co., Ltd.]
THE SIMPLE INITIAL KIT; INITIAL KIT; INITIAL2018-12-03
Jun Song [ACRODENT Co., Ltd.]
THE SIMPLE GUIDE KIT; GUIDE KIT; GUIDE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
THE SIMPLE CHECK KIT; CHECK KIT; CHECK2018-12-03
Jun Song [ACRODENT Co., Ltd.]
SPRING FOR MINI BONE PEN; SPRING2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL PIN YELLOW 6MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL PIN MAUVE 8MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL PIN GREEN 7MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL PIN BLUE 9MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL PIN AQUA 10MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL PEN SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL PEN MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL CUP YELLOW 6MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL CUP MAUVE 8MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL CUP GREEN 7MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL CUP BLUE 9MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
INITIAL CUP AQUA 10MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
IMPLANT SURGICAL KIT; IMPLANT POSITIONING KIT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
IMPLANT GUIDE SYSTEM; IMPLANT SURGICAL SYSTEM; IMPLANT SYSTEM; IMPLANT KIT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
HEX DRIVER (WRENCH TYPE) SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
HEX DRIVER (WRENCH TYPE) MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
HEX DRIVER (HANDPIECE TYPE)2018-12-03
Jun Song [ACRODENT Co., Ltd.]
GINGIVAL SHAPER 9MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
GINGIVAL SHAPER 8MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
GINGIVAL SHAPER 7MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
GINGIVAL SHAPER 6MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
GINGIVAL SHAPER 10MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
GBR PEN2018-12-03
Jun Song [ACRODENT Co., Ltd.]
FINAL DRILL 50 SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
FINAL DRILL 50 MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
FINAL DRILL 45 SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
FINAL DRILL 45 MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
FINAL DRILL 40 SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
FINAL DRILL 40 MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
EXTENDER NOMAL2018-12-03
Jun Song [ACRODENT Co., Ltd.]
COUNTERSINK 502018-12-03
Jun Song [ACRODENT Co., Ltd.]
COUNTERSINK 452018-12-03
Jun Song [ACRODENT Co., Ltd.]
COUNTERSINK 402018-12-03
Jun Song [ACRODENT Co., Ltd.]
CHECK PIN YELLOW 6MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
CHECK PIN MAUVE 8MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
CHECK PIN GREEN 7MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
CHECK PIN BLUE 9MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
CHECK PIN AQUA 10MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONESHAPER 9MM SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONESHAPER 9MM MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONESHAPER 8MM SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONESHAPER 8MM MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONESHAPER 7MM SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONESHAPER 7MM MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONESHAPER 6MM SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONESHAPER 6MM MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONESHAPER 10MM SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONESHAPER 10MM MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PRO2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PIN YELLOW 6MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PIN MAUVE 8MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PIN GREEN 7MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PIN BLUE 9MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PIN AQUA 10MM2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PEN(W/DRILL) YELLOW 6MM MINI2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PEN(W/DRILL) MAUVE 8MM MINI2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PEN(W/DRILL) GREEN 7MM MINI2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PEN(W/DRILL) BLUE 9MM MINI2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN PEN(W/DRILL) AQUA 10MM MINI2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN MINI2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN BASIC2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONEPEN BASIC MINI2018-12-03
Jun Song [ACRODENT Co., Ltd.]
BONE TRIMMER (D4.0)2018-12-03
Jun Song [ACRODENT Co., Ltd.]
ADAPTOR (WRENCH TYPE) SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
ADAPTOR (WRENCH TYPE) MIDDLE2018-12-03
Jun Song [ACRODENT Co., Ltd.]
ADAPTOR (HANDPIECE TYPE) SHORT2018-12-03
Jun Song [ACRODENT Co., Ltd.]
ADAPTOR (HANDPIECE TYPE) MIDDLE2018-12-03

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