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Data / Medical devices / Croatia / LLD Care D.O.O.

LLD Care D.O.O.: FDA-registered device maker in Zagreb Zagreb, Grad, Croatia, 19 510(k) clearances

LLD Care D.O.O. is registered with the FDA (registration 3042244574) in Zagreb Zagreb, Grad, Croatia. It lists 33 device types. The FDA files 19 510(k) clearances under its listings, the newest dated August 12, 2022. 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 LLD Care D.O.O.
FDA registration number
3042244574
Address
Mrksina 11c, Zagreb Zagreb, Grad, Croatia, 10020
Owner or operator
LLD Care d.o.o. (10094252)
Roles
Exporter to the US
First device listed
November 20, 2025
Registered through
2027
Brand names listed
Agent, Tooth Bonding, Aluminum Oxide, Aquasil Ultra, Biogreen applicators, BriteShield, Cavity Conditioner, Contact Matrix, DENMAT PREC JAR and more

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Polishing, Abrasive, Oral CavityEJR1Exporter to the USaccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Exporter to the USaccessdata.fda.gov
AirbrushKOJ2Exporter to the USaccessdata.fda.gov
Applicator, ResinKXR1Exporter to the USaccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Exporter to the USaccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Carrier, Amalgam, OperativeEKI1Exporter to the USaccessdata.fda.gov
Catheter, IrrigationGBX1Exporter to the USaccessdata.fda.gov
Cement, DentalEMA2Exporter to the USaccessdata.fda.gov
Cleaner, Denture, MechanicalJER1Exporter to the USaccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Exporter to the USaccessdata.fda.gov
Cotton, RollEFN1Exporter to the USaccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Exporter to the USaccessdata.fda.gov
Cup, ProphylaxisEHK1Exporter to the USaccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Exporter to the USaccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Exporter to the USaccessdata.fda.gov
Holder, Film, X-RayEGZ1Exporter to the USaccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Exporter to the USaccessdata.fda.gov
Instrument, Hand, Calculus RemovalELA1Exporter to the USaccessdata.fda.gov
Instruments, Dental HandDZN1Exporter to the USaccessdata.fda.gov
Material, ImpressionELW2Exporter to the USaccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Exporter to the USaccessdata.fda.gov
Powder, PorcelainEIH2Exporter to the USaccessdata.fda.gov
Preparer, Root Canal EndodonticEKQ1Exporter to the USaccessdata.fda.gov
Probe, PeriodonticEIX1Exporter to the USaccessdata.fda.gov
Retainer, MatrixJEP1Exporter to the USaccessdata.fda.gov
RetractorGAD1Exporter to the USaccessdata.fda.gov
Retractor, All TypesEIG1Exporter to the USaccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Exporter to the USaccessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2Exporter to the USaccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Exporter to the USaccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Exporter to the USaccessdata.fda.gov
Tray, Impression, PreformedEHY1Exporter 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
August 12, 2022K221126Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancetsFMKSubstantially EquivalentOwen Mumford, Ltd.accessdata.fda.gov
June 13, 2022K2216953M Filtek Supreme Flowable RestorativeEBFSubstantially Equivalent3M Company Espe Dental Productsaccessdata.fda.gov
July 11, 2019K182854GC FujiCEM 2 (Improved)EMASubstantially EquivalentGC America, Inc.accessdata.fda.gov
September 28, 2018K181476Prime&Bond active Universal AdhesiveKLESubstantially EquivalentDentsply Sironaaccessdata.fda.gov
March 4, 2016K152861Aquasil Ultra + Smart Wetting Impression MaterialELWSubstantially EquivalentDentply International, Inc.accessdata.fda.gov
February 22, 2013K123615IRIS - HIGH STRENGTH GLASS CERAMICEIHSubstantially EquivalentDentsply Intl.accessdata.fda.gov
September 16, 2009K092319STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387ELWSubstantially EquivalentDanville Materials, Inc.accessdata.fda.gov
March 25, 2004K040053PRECISION VPS IMPRESSION MATERIALELWSubstantially EquivalentDiscus Dental, Inc.accessdata.fda.gov
January 26, 2004K033309PREMIER IMPLANT CEMENT, MODEL 3001450EMASubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
January 24, 2002K013674LUXATEMP/LUXATEMP SOLAR/INSTATEMPEBGSubstantially EquivalentDmg USA, Inc.accessdata.fda.gov
January 13, 1999K984387R-30 AESTHETIC RESTORATIVEEBFSubstantially EquivalentDentsply Intl.accessdata.fda.gov
February 9, 1998K973221COMPOSITE 168 RESTORATIVE SYSTEMEBFSubstantially EquivalentDentsply Intl.accessdata.fda.gov
October 3, 1995K953504MICROPRIMEKLESubstantially EquivalentDanville Engineering, Inc.accessdata.fda.gov
September 27, 1995K953166FUJI BOND LCKLESubstantially EquivalentGC America, Inc.accessdata.fda.gov
January 20, 1995K946100FUJI DUETEMASubstantially EquivalentGC America, Inc.accessdata.fda.gov
October 30, 1991K913884FUJI II LCEMASubstantially EquivalentG-C Intl. Corp.accessdata.fda.gov
November 20, 1990K902836MICROETCHERKOJSubstantially EquivalentDanville Engineering, Inc.accessdata.fda.gov
August 7, 1980K801142PALODENT MATRICES & BITINE RINGSDZNSubstantially EquivalentAlvin Meyer, D.D.S.accessdata.fda.gov
August 31, 1978K781151REPROSILELWSubstantially EquivalentDentsply Intl.accessdata.fda.gov

Compare with other makers

Updated August 12, 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.