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Data / Medical devices / Turkey / Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.

Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.: FDA-registered device maker in Konya, Turkey, 6 510(k) clearances

Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. is registered with the FDA (registration 3005176727) in Konya, Turkey. It lists 41 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 9, 2022. Registered through 2026. FDA data exported November 3, 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 Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S.
FDA registration number
3005176727
Address
Fetih Mahallesi Mahir Sokak No:5/201 Karatay/Konya, Konya, Turkey, 42030
Owner or operator
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. (10062241)
Roles
Manufacturer, Repackager or relabeler
First device listed
January 2, 2020
Registered through
2026
Brand names listed
AMALGAMAX, ARTICULATORS, CERAXIDIN-C, Vayfic, PAMA Solution, Imisemme, Traysemme, Calciplus LC, Calciplus RL, Calciplus, Imical, Biofactor MTA, Therra, Cavitimi, Ceramica, Clean & Clean Bibs and Cover, DENTAL ABSORBER, SALIVA, PAPER, DENTAL ALLOY and more

Devices it lists

DeviceProduct codeClassRoleSource
Absorber, Saliva, PaperKHR1Repackager or relabeleraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Manufactureraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Manufactureraccessdata.fda.gov
Alloy, Metal, BaseEJH2Repackager or relabeleraccessdata.fda.gov
Alloy, Other Noble MetalEJS2Repackager or relabeleraccessdata.fda.gov
Amalgamator, Dental, Ac-PoweredEFD1Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Manufactureraccessdata.fda.gov
Applicator, ResinKXR1Manufactureraccessdata.fda.gov
Apron, ProtectiveIWO1Manufactureraccessdata.fda.gov
ArticulatorsEJP1Repackager or relabeleraccessdata.fda.gov
Bur, DentalEJL1Repackager or relabeleraccessdata.fda.gov
Capsule, Dental, AmalgamDZS1Repackager or relabeleraccessdata.fda.gov
Cement, DentalEMA2Manufactureraccessdata.fda.gov
Cleanser, Denture, PrescriptionNUX1Repackager or relabeleraccessdata.fda.gov
Cotton, RollEFN1Repackager or relabeleraccessdata.fda.gov
Cushion, Pad, Denture, Wax Impregnated Cotton, Over The CounterNKJ1Manufactureraccessdata.fda.gov
Denture, Plastic, TeethELM2Manufactureraccessdata.fda.gov
Dentures, FullNSLNManufactureraccessdata.fda.gov
Dentures, PartialNSKNManufactureraccessdata.fda.gov
Disk, AbrasiveEHJ1Repackager or relabeleraccessdata.fda.gov
External Cleaning SolutionPME2Manufactureraccessdata.fda.gov
Gutta-PerchaEKM1Repackager or relabeleraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Repackager or relabeleraccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Manufactureraccessdata.fda.gov
Material, ImpressionELW2Manufactureraccessdata.fda.gov
Material, Impression Tray, ResinEBH1Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Mixer, Cement, For Clinical UseJDZ1Manufactureraccessdata.fda.gov
Pin, Retentive And Splinting, And Accessory InstrumentsEBL1Manufactureraccessdata.fda.gov
Plate, Base, ShellacEEA1Manufactureraccessdata.fda.gov
Point, Paper, EndodonticEKN1Repackager or relabeleraccessdata.fda.gov
Preparer, Root Canal EndodonticEKQ1Manufactureraccessdata.fda.gov
Restoration, PorcelainNSPNManufactureraccessdata.fda.gov
Restoration, ResinNSMNManufactureraccessdata.fda.gov
Restoration, Resin, Crown And BridgeNSNNManufactureraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Manufactureraccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Manufactureraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Manufactureraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Repackager or relabeleraccessdata.fda.gov
Zinc Oxide EugenolEMB1Manufactureraccessdata.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 9, 2022K220077IMICRYL Composite, Composite Flow MaterialsEBFSubstantially EquivalentImicryl Dis Malzemeleri Sanayi VE Ticaret ASaccessdata.fda.gov
August 9, 2022K213609NOVA RESIN dual cure, self adhesive resin cementEMASubstantially EquivalentImicryl Dis Malzemeleri Sanayi VE Ticaret ASaccessdata.fda.gov
February 11, 2022K213890IMICRYL Impression MaterialsELWSubstantially EquivalentImicryl Dis Malzemeleri San. VE Tic. A.S.accessdata.fda.gov
November 2, 2021K210473Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus)EMASubstantially EquivalentImicryl Dis Malzemeleri Sanayi VE Ticaret ASaccessdata.fda.gov
January 19, 2021K192913R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseKLESubstantially EquivalentImicryl Dis Malzemeleri Sanayi VE Ticaret ASaccessdata.fda.gov
December 20, 2019K192178R&D Series Nova Compo NEBFSubstantially EquivalentImicryl Dis Malzemeleri Sanayi VE Ticaret ASaccessdata.fda.gov

Compare with other makers

Updated August 9, 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.