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Data / Medical devices / Spain / B.T.I. Biotechnology Institute, S.L.

B.T.I. Biotechnology Institute, S.L.: FDA-registered device maker in Miñano Alava, Spain, 19 510(k) clearances

B.T.I. Biotechnology Institute, S.L. is registered with the FDA (registration 3004417597) in Miñano Alava, Spain. It lists 33 device types. The FDA files 19 510(k) clearances under its listings, the newest dated October 10, 2024. 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 B.T.I. Biotechnology Institute, S.L.
FDA registration number
3004417597
Address
Leonardo Da Vinci 14, Miñano Alava, Spain, 01510
Owner or operator
B.T.I. BIOTECHNOLOGY (9052086)
Roles
Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed
May 26, 2004
Registered through
2026
Brand names listed
INPESPA1

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Accessories, Implant, Dental, EndosseousNDP1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Attachment, Precision, AllEGG1Exporter to the USaccessdata.fda.gov
Blade, ScalpelGES1Exporter to the USaccessdata.fda.gov
Bur, DentalEJL1Manufacturer, Specification developeraccessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical UseJQC1Manufactureraccessdata.fda.gov
Clinical Sample ConcentratorJJH1Manufactureraccessdata.fda.gov
CountersinkHWW1Manufactureraccessdata.fda.gov
Curette, PeriodonticEMS1Exporter to the USaccessdata.fda.gov
Curette, Surgical, DentalEMK1Exporter to the USaccessdata.fda.gov
Dental Implant Surgical TrayOFY1Manufactureraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseLXG1Exporter to the US, Manufactureraccessdata.fda.gov
Filter, Conduction, AnestheticBSN2Exporter to the USaccessdata.fda.gov
Forceps, Dressing, DentalEFL1Exporter to the USaccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Exporter to the USaccessdata.fda.gov
Handle, Instrument, DentalEJB1Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov
Handle, ScalpelGDZ1Exporter to the USaccessdata.fda.gov
Hemostat, SurgicalEMD1Exporter to the USaccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Exporter to the USaccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Exporter to the USaccessdata.fda.gov
Needle, Hypodermic, Single LumenFMI2Exporter to the USaccessdata.fda.gov
Platelet And Plasma Separator For Bone Graft HandlingORG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Exporter to the USaccessdata.fda.gov
Retractor, All TypesEIG1Exporter to the USaccessdata.fda.gov
Scaler, PeriodonticEMN1Exporter to the USaccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Exporter to the USaccessdata.fda.gov
Syringe, AntistickMEG2Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Exporter to the USaccessdata.fda.gov
Tourniquet, NonpneumaticGAX1Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the US, Manufacturer, Specification developeraccessdata.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 10, 2024K240262BTI Interna 3.0 Dental Implant System UnicCa®DZESubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
December 8, 2023K232750BTI Interna Prosthetic ComponentsNHASubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
September 15, 2023K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsNHASubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
October 20, 2022K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsNHASubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
July 21, 2022K211952BTI Interna Narrow/Plus Dental Implant System UnicCaDZESubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
July 29, 2021K202825BTI Extra-Short Dental Implant System UnicCaDZESubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
August 17, 2018K173257BTI Dental Implant System UnicCaDZESubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
August 9, 2018K180417Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single UseMEGSubstantially EquivalentBerpu Medical Technology Co., Ltd.accessdata.fda.gov
May 2, 2016K151391BTI Dental Implant System UnicCaDZESubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
October 6, 2009K092112BTI DENTAL IMPLANT TINY 2.5-3.0DZESubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
December 3, 2007K072878MODIFICATION TO: LOCATOR IMPLANT ANCHORNHASubstantially EquivalentZest Anchors, Inc.accessdata.fda.gov
June 21, 2007K070533BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTSNHASubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
August 3, 2006K061383BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPSEJLSubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
March 14, 2006K053355BTI INTERNA DENTAL IMPLANT SYSTEMDZESubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
September 11, 2003K022258B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. DENTAL IMPLANT SYSTEMDZESubstantially EquivalentB.T.I. Biotechnology Institute, Sl.accessdata.fda.gov
April 4, 2002K013988MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 RBSNSubstantially EquivalentMillipore Corp.accessdata.fda.gov
July 12, 2001K011786VACUETTE SAFETY BLOOD COLLECTION SETFMISubstantially EquivalentGreiner Vacuette North America, Inc.accessdata.fda.gov
October 1, 1999K992734BECTON DICKINSON SYRINGEMEGSubstantially EquivalentBd Becton Dickinson Vacutainer Systems Preanalyticaccessdata.fda.gov
October 30, 1998K983067FINE-JECTFMISubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov

Compare with other makers

Updated October 10, 2024. 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.