FDA.reportPublic FDA data

DENTIUM CO., LTD.

Matched from indexed company URL: DENTIUM, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30045788073004578807DENTIUM CO., LTD.1N2026-01-0176, Changnyong-daero 256beon-gil, Yeongtong-gu Suwon-si Gyeonggi KR 16229
30055032423005503242Dentium USA1Y2026-01-016761 Katella Ave. CYPRESS CA US 90630
30174032453017403245DENTIUM CO.,LTD(ICT BRANCH)1N2026-01-01(16229) 76, Changnyong-daero 256beon-gil, Yeongtong-gu Suwon Gyeonggi KR 16229
30310933883031093388DENTIUM CO.,LTD(ICT BRANCH)1N2026-01-01(16985) 150, Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do Yongin Gyeonggi KR 16985

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08809544909914Implantium, Superline - Accessories, Implant, Dental, Endosseous+1(714)226-0229cs@dentiumusa.com
08809544909921Implantium, Superline - Accessories, Implant, Dental, Endosseous+1(714)226-0229cs@dentiumusa.com
08809544909938Implantium, Superline - Accessories, Implant, Dental, Endosseous+1(714)226-0229cs@dentiumusa.com
08809544909945Implantium, Superline - Accessories, Implant, Dental, Endosseous+1(714)226-0229cs@dentiumusa.com
08809544909952Implantium, Superline - Accessories, Implant, Dental, Endosseous+1(714)226-0229cs@dentiumusa.com
08809544909969Implantium, Superline - Accessories, Implant, Dental, Endosseous+1(714)226-0229cs@dentiumusa.com
08809544909976Implantium, Superline - Accessories, Implant, Dental, Endosseous+1(714)226-0229cs@dentiumusa.com
08809740719393Implantium, Superline - Accessories, Implant, Dental, Endosseous+1(714)226-0229cs@dentiumusa.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3273691190692030K231181bright CTOAS2023-12-14
2735751190692030K231181bright CTOAS2023-12-14
229321134644577K213599SuperLineDZE2022-02-23
229311134644577K213599SuperLineDZE2022-02-23
2735751123717802K201247Intraoral SensorMQB2020-06-10
2735751897966256K200271rainbow CTOAS2021-04-16
3273691897966256K200271rainbow CTOAS2021-04-16
2735751800284678K200270rainbow MCTOAS2021-04-16
3273691800284678K200270rainbow MCTOAS2021-04-16
2735751563739407K193341iCTmotor (WL-1)EBW2020-09-04
3273691563739407K193341iCTmotor (WL-1)EBW2020-09-04
229311786566769K192436Healing Abutments and Cover ScrewsNHA2020-01-23
229311818860641K191634Scan Abutments and Comfort CapsNHA2019-11-04
229311903044116K172640Dentium Implantium & SuperLine ProstheticsNHA2018-05-14
229321903044116K172640Dentium Implantium & SuperLine ProstheticsNHA2018-05-14
229311382483624K171622Dentium Ti-BaseNHA2018-01-11
229311161142505K171126Implantium IIDZE2017-09-07
229311909421780K170384Dentium NR Line CAD/CAM AbutmentsNHA2017-08-17
229311579522056K161713Dentium CAD/CAM AbutmentsNHA2016-12-16
229321579522056K161713Dentium CAD/CAM AbutmentsNHA2016-12-16
229311356670347K160965SuperLineDZE2017-01-13
229321356670347K160965SuperLineDZE2017-01-13
229311183098225K160828Dentium Implantium & SuperLine ProstheticsNHA2016-09-15
229312014001101K160483Burn-out Cylinder and Angled Screw AbutmentsNHA2016-08-05
229311589005882K153268NR Line Implant SystemDZE2016-07-20
229311731428711K141457DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTSNHA2014-11-12
229311311384370K112045SIMPLELINE II ABUTMENT SYSTEMNHA2012-01-26
229311554602562K111162SLIM ONEBODY SYSTEMDZE2012-01-13
229321554602562K111162SLIM ONEBODY SYSTEMDZE2012-01-13
229311778243755K102308SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELSDZE2010-11-22
229311685012577K052957IMPLANTIUM PROSTHETICSNHA2006-07-27
229321685012577K052957IMPLANTIUM PROSTHETICSNHA2006-07-27
229321605789732K041368DENTIUM CO., LTD. IMPLANTIUMDZE2004-07-29
229311605789732K041368DENTIUM CO., LTD. IMPLANTIUMDZE2004-07-29
229311071186434
229321071186434
229311101794418
229311208482029
229311288558675
229311293936861
229311424540642
229311479579023
229311572712496
229312030139170

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA242020-01-23
DZE152022-02-23
OAS62023-12-14
EBW22020-09-04
MQB12020-06-10

PMN#

bright CT

2023-12-14

Dentium Co., Ltd (Ict Branch)

GUDID#

80 records. Showing 1-40. Next