510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dentium Co., Ltd.

Suwon-si Gyeonggi, KR

DENTIUM CO., LTD. appears in FDA device records in Suwon-si Gyeonggi, KR. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
23
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 23 510(k) clearances for Dentium Co., Ltd. between 2004 and 2022. The busiest year on record is 2006, with 4. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Dentium Co., Ltd., by decision year
YearClearances
20041
20064
20071
20101
20122
20141
20164
20173
20182
20191
20202
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K213599SuperLineDZESubstantially Equivalent
K193341iCTmotor (WL-1)EBWSubstantially Equivalent
K192436Healing Abutments and Cover ScrewsNHASubstantially Equivalent
K191634Scan Abutments and Comfort CapsNHASubstantially Equivalent
K172640Dentium Implantium & SuperLine ProstheticsNHASubstantially Equivalent
K171622Dentium Ti-BaseNHASubstantially Equivalent
K171126Implantium IIDZESubstantially Equivalent
K170384Dentium NR Line CAD/CAM AbutmentsNHASubstantially Equivalent
K160965SuperLineDZESubstantially Equivalent
K161713Dentium CAD/CAM AbutmentsNHASubstantially Equivalent
K160828Dentium Implantium & SuperLine ProstheticsNHASubstantially Equivalent
K160483Burn-out Cylinder and Angled Screw AbutmentsNHASubstantially Equivalent
K153268NR Line Implant SystemDZESubstantially Equivalent
K141457DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTSNHASubstantially Equivalent
K112045SIMPLELINE II ABUTMENT SYSTEMNHASubstantially Equivalent
K111162SLIM ONEBODY SYSTEMDZESubstantially Equivalent
K102308SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELSDZESubstantially Equivalent
K070228IMPLANTIUM PROSTHETICSNHASubstantially Equivalent
K052957IMPLANTIUM PROSTHETICSNHASubstantially Equivalent
K060501IMPLANTIUM IIDZESubstantially Equivalent
K060500SPEEDY ORTHODONTIC SCREWDZESubstantially Equivalent
K052823IMPLANTIUM ABUTMENTSNHASubstantially Equivalent
K041368DENTIUM CO., LTD. IMPLANTIUMDZESubstantially Equivalent

Registered establishments

FDA registered establishments for Dentium Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30045788073004578807DENTIUM CO., LTD.76, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si Gyeonggi 16229 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain