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Data / Medical devices / South Korea / Spident Co., Ltd.

Spident Co., Ltd.: FDA-registered device maker in INCHEON Gyeonggi, South Korea, 23 510(k) clearances

Spident Co., Ltd. is registered with the FDA (registration 3006113314) in INCHEON Gyeonggi, South Korea. It lists 19 device types. The FDA files 23 510(k) clearances under its listings, the newest dated October 13, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Spident Co., Ltd.
FDA registration number
3006113314
Address
312, 151B-6L Namdonggongdan, INCHEON Gyeonggi, South Korea, 405-821
Owner or operator
SPIDENT CO., LTD. (9089446)
Roles
Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
July 6, 2006
Registered through
2027
Brand names listed
Absorbent Paper Accessory Points, BLooming Gloves, BLooming Masks, Base It, Block-Out Resin, Bonding Agent, Core It Dual, EsBond and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Retractor, DentalEIF1Exporter to the USaccessdata.fda.gov
Activator, Ultraviolet, For PolymerizationEBZ2Repackager or relabeleraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Manufactureraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Manufactureraccessdata.fda.gov
Cement, DentalEMA2Manufactureraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Manufactureraccessdata.fda.gov
Dam, RubberEIE1Manufactureraccessdata.fda.gov
Gutta-PerchaEKM1Manufactureraccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Manufactureraccessdata.fda.gov
Mask, SurgicalFXX2Repackager or relabeleraccessdata.fda.gov
Material, ImpressionELW2Manufactureraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Manufactureraccessdata.fda.gov
Needle, DentalDZM1Manufactureraccessdata.fda.gov
Patient Examination GloveFMC1Repackager or relabeleraccessdata.fda.gov
Point, Paper, EndodonticEKN1Manufactureraccessdata.fda.gov
Preparer, Root Canal EndodonticEKQ1Manufactureraccessdata.fda.gov
Resin, Root Canal FillingKIF2Manufactureraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 13, 2026K262433OrthoFit Aligner (OrthoFit Aligner A2)DYHSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
September 11, 2026K262050Vioseal XKIFSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
July 2, 2026K261129OrthoFitDYHSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
June 20, 2025K250566EsCem RMGIEMASubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
May 30, 2025K250317EsFlow PLUSEBFSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
November 7, 2024K242702VioSealKIFSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
November 1, 2024K242675FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)KLESubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
July 22, 2024K241445K-Bond UniversalKLESubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
July 24, 2023K231523EsCom250EBFSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
December 19, 2022K214076EsCemEMASubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
March 10, 2022K214071Hexa-TempEBGSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
September 30, 2016K161774i-SilELWSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
June 11, 2014K134022BASE ITEJKSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
June 10, 2014K134021ESTEMP IMPLANT, ESTEMP CLEAREMASubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
May 24, 2012K120767ES BONDKLESubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
May 3, 2012K120768ES FLOWEBFSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
February 25, 2011K110428ESCOM 100EBFSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
March 3, 2010K100413TEMP ITEBFSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
February 24, 2010K093751CL-DC20, CL-DC21EBZSubstantially EquivalentGood Doctors Co., Ltd.accessdata.fda.gov
February 17, 2010K100290ESTEMP NEEMASubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
August 26, 2009K092572CORE*IT DUALEBFSubstantially EquivalentSpident Co., Ltd.accessdata.fda.gov
June 10, 2003K023755WINNER EAR LOOP PROCEDURE MASK, TIE-ON SURGICAL MASK & EAR LOOP PROCEDURE MASK WITH SHIELDFXXSubstantially EquivalentWinner Industries (Shenzhen) Co., Ltd.accessdata.fda.gov
August 17, 1999K992337BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTAFMCSubstantially EquivalentMexpo Intl., Inc.accessdata.fda.gov

Compare with other makers

Updated October 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.