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

INCHEON Gyeonggi, KR

SPIDENT CO., LTD. appears in FDA device records in INCHEON Gyeonggi, KR. FDA records list 18 510(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
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Spident Co., Ltd. between 2009 and 2026. The busiest year on record is 2024, with 3. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Spident Co., Ltd., by decision year
YearClearances
20091
20102
20111
20122
20142
20161
20222
20231
20243
20252
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261129OrthoFitDYHSubstantially Equivalent
K250566EsCem RMGIEMASubstantially Equivalent
K250317EsFlow PLUSEBFSubstantially Equivalent
K242702VioSealKIFSubstantially Equivalent
K242675FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)KLESubstantially Equivalent
K241445K-Bond UniversalKLESubstantially Equivalent
K231523EsCom250EBFSubstantially Equivalent
K214076EsCemEMASubstantially Equivalent
K214071Hexa-TempEBGSubstantially Equivalent
K161774i-SilELWSubstantially Equivalent
K134022BASE ITEJKSubstantially Equivalent
K134021ESTEMP IMPLANT, ESTEMP CLEAREMASubstantially Equivalent
K120767ES BONDKLESubstantially Equivalent
K120768ES FLOWEBFSubstantially Equivalent
K110428ESCOM 100EBFSubstantially Equivalent
K100413TEMP ITEBFSubstantially Equivalent
K100290ESTEMP NEEMASubstantially Equivalent
K092572CORE*IT DUALEBFSubstantially Equivalent

Registered establishments

FDA registered establishments for Spident Co., Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30061133143006113314SPIDENT CO., LTD.312, 151B-6L NAMDONGGONGDAN, INCHEON Gyeonggi 405-821 KR2026and 9 more, listed in full below

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

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