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Data / Medical devices / South Korea / Zapalign Inc.

Zapalign Inc.: FDA-registered device maker in Anyang-si Gyeonggi, South Korea, 23 510(k) clearances

Zapalign Inc. is registered with the FDA (registration 3011944170) in Anyang-si Gyeonggi, South Korea. It lists 22 device types. The FDA files 23 510(k) clearances under its listings, the newest dated June 13, 2022. Registered through 2026. 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 Zapalign Inc.
FDA registration number
3011944170
Address
#1004, 10F, 181, Simin-daero, Dongan-gu, Anyang-si Gyeonggi, South Korea, 14047
Owner or operator
Zapalign Inc. (10091758)
Roles
Exporter to the US
First device listed
October 30, 2024
Registered through
2026
Brand names listed
AGENT, TOOTH BONDING, RESIN, BUR, SURGICAL, GENERAL & PLASTIC SURGERY, Blade, Saw, General & Plastic Surgery, Surgical, CEMENT, DENTAL, COLORADO MICRO DISSECTION NEEDLE, CROWN AND BRIDGE, TEMPORARY, RESIN, CROWN, PREFORMED, Cavitron and more

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Tooth Bonding, ResinKLE2Exporter to the USaccessdata.fda.gov
ArthroscopeHRX2Exporter to the USaccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Exporter to the USaccessdata.fda.gov
Bur, Surgical, General & Plastic SurgeryGFF1Exporter to the USaccessdata.fda.gov
Cement, DentalEMA2Exporter to the USaccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Exporter to the USaccessdata.fda.gov
Crown, PreformedELZ1Exporter to the USaccessdata.fda.gov
Dental Barriers And SleevesPEM2Exporter to the USaccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the USaccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Exporter to the USaccessdata.fda.gov
Holder, Film, X-RayEGZ1Exporter to the USaccessdata.fda.gov
Material, ImpressionELW2Exporter to the USaccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Exporter to the USaccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Exporter to the USaccessdata.fda.gov
Scaler, UltrasonicELC2Exporter to the USaccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Exporter to the USaccessdata.fda.gov
Set, Administration, IntravascularFPA2Exporter to the USaccessdata.fda.gov
Surgeon'S GlovesKGO1Exporter to the USaccessdata.fda.gov
System, Irrigation, UrologicalLJH2Exporter to the USaccessdata.fda.gov
System, Skin ClosureMKY1Exporter to the USaccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Exporter to the USaccessdata.fda.gov
Zinc Oxide EugenolEMB1Exporter to the USaccessdata.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
June 13, 2022K2216953M Filtek Supreme Flowable RestorativeEBFSubstantially Equivalent3M Company Espe Dental Productsaccessdata.fda.gov
October 31, 2019K192961ADH19KLESubstantially Equivalent3M Deutschland GmbHaccessdata.fda.gov
January 2, 2019K1834763M Filtek Universal RestorativeEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
November 28, 2016K163207Filtek One Bulk Fill RestorativeEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
September 27, 2016K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyEKXSubstantially EquivalentDentsply Sironaaccessdata.fda.gov
June 7, 2016K160232Disposable Barrier Sleeves and CoversPEMSubstantially EquivalentDentsply International, Inc.accessdata.fda.gov
August 18, 2014K142011SOLUTION SET/EXTENSION SETFPASubstantially EquivalentBaxter Healthcare Corporationaccessdata.fda.gov
March 19, 2012K120453FILTEK BULK FILL FLOWABLE RESTORATIVEEBFSubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
May 12, 2010K100235FILTEK SUPREME ULTRA FLOWABLE RESTORATIVEEBFSubstantially Equivalent3M Companyaccessdata.fda.gov
October 25, 2006K062292UNICEMEMASubstantially Equivalent3M Espe Dental Productsaccessdata.fda.gov
May 12, 2005K050600MINILOC SAFETY INFUSION SETFPASubstantially EquivalentSpecialized Health Products, Intl.accessdata.fda.gov
February 25, 2004K033232COLORADO MICRODISSECTION NEEDLEGEISubstantially EquivalentStryker Corp.accessdata.fda.gov
August 11, 2003K032001POLY Q (GARANT L, PENTA M, PENTA H)ELWSubstantially Equivalent3M Espe AG Dental Productsaccessdata.fda.gov
September 28, 2000K0024523M RELY X VENEER CEMENT TRY-IN PASTEREMASubstantially Equivalent3M Companyaccessdata.fda.gov
February 26, 1999K984558DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)KGOSubstantially EquivalentAnsell Perryaccessdata.fda.gov
June 5, 1998K973201PROVI CEMENTEMASubstantially EquivalentS & C Polymer GmbHaccessdata.fda.gov
April 11, 1997K970123DENTSPLY CAVITRON SPS SCALER SYSTEMELCSubstantially EquivalentDentsply Intl.accessdata.fda.gov
May 14, 1996K960787TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETSLJHSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
January 5, 1994K9331393M VITREMER LUTING CEMENTEMASubstantially Equivalent3M Companyaccessdata.fda.gov
June 18, 1993K925027PHOTAC-FIL APLICAPEMASubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
March 20, 1992K920424SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEMKLESubstantially Equivalent3M Companyaccessdata.fda.gov
March 1, 1988K875133CAVIT-WEBGSubstantially EquivalentEspe GmbH (Us)accessdata.fda.gov
March 18, 1980K800485VINYL POLYSILOXANE IMPRESSION MATERIALELWSubstantially Equivalent3M Companyaccessdata.fda.gov

Compare with other makers

Updated June 13, 2022. 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.