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Data / Medical devices / Italy / Kerr Italia, S.r.l.

Kerr Italia, S.r.l.: FDA-registered device maker in SCAFATI Salerno, Italy, 34 510(k) clearances

Kerr Italia, S.r.l. is registered with the FDA (registration 8020994) in SCAFATI Salerno, Italy. It lists 25 device types. The FDA files 34 510(k) clearances under its listings, the newest dated January 12, 2023. 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 Kerr Italia, S.r.l.
FDA registration number
8020994
FEI number
1000231788
Address
Via Passanti, 174, SCAFATI Salerno, Italy, 84018
Owner or operator
SYBRON DENTAL SPECIALTIES, INC. (9029565)
Roles
Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 15, 1977
Registered through
2027
Brand names listed
37% Phosphoric Acid Etching Gel, AXIS Laminate Veneer Set, Acrylic Adjustment Logic Set, Adapt Luciwedge, AlgiNot, All Ceramic Logic Set, All-Purpose Esthetic Logic Set, Anterior Composite Logic Set and more

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Polishing, Abrasive, Oral CavityEJR1Manufactureraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Bur, DentalEJL1Manufactureraccessdata.fda.gov
Cement, DentalEMA2Contract manufacturer, Manufactureraccessdata.fda.gov
Crown And Bridge, Temporary, ResinEBG2Manufactureraccessdata.fda.gov
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain ReliefMZW2Contract manufactureraccessdata.fda.gov
Disk, AbrasiveEHJ1Manufactureraccessdata.fda.gov
File, Pulp Canal, EndodonticEKS1Manufactureraccessdata.fda.gov
Gutta-PerchaEKM1Manufactureraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Manufactureraccessdata.fda.gov
Instruments, Dental HandDZN1Manufactureraccessdata.fda.gov
Liner, Cavity, Calcium HydroxideEJK2Contract manufactureraccessdata.fda.gov
Material, ImpressionELW2Manufactureraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Manufactureraccessdata.fda.gov
Point, AbrasiveEHL1Contract manufacturer, Manufactureraccessdata.fda.gov
Point, Paper, EndodonticEKN1Specification developeraccessdata.fda.gov
Post, Root CanalELR1Manufactureraccessdata.fda.gov
Reamer, Pulp Canal, EndodonticEKP1Specification developeraccessdata.fda.gov
Resin, Root Canal FillingKIF2Manufactureraccessdata.fda.gov
Retainer, MatrixJEP1Manufactureraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Manufactureraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Repackager or relabeleraccessdata.fda.gov
Unit, Operative DentalEIA1Manufactureraccessdata.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
January 12, 2023K222830Rainbow 360KLESubstantially EquivalentKerr Corporationaccessdata.fda.gov
August 31, 2022K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowEBFSubstantially EquivalentKerr Corporationaccessdata.fda.gov
November 7, 2018K182162OptiBond eXTRa UniversalKLESubstantially EquivalentKerr Corporationaccessdata.fda.gov
November 7, 2016K162257P1145 Dental RestorativeEBFSubstantially EquivalentKerr Corporationaccessdata.fda.gov
July 27, 2016K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressKIFSubstantially EquivalentSybron Dental Specialtiesaccessdata.fda.gov
May 6, 2016K152956Pulp Canal Sealer, Pulp Canal Sealer EWTKIFSubstantially EquivalentSybron Dental Specialtiesaccessdata.fda.gov
April 14, 2016K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIFSubstantially EquivalentSybron Dental Specialtiesaccessdata.fda.gov
August 17, 2015K151332Nexus Universal, Nexus Universal ChromaEMASubstantially EquivalentSybron Dental Specialtiesaccessdata.fda.gov
February 5, 2015K143209SonicFill 2EBFSubstantially EquivalentSybron Dental Specialtiesaccessdata.fda.gov
May 30, 2013K130869TAKE 1 ADVANCEELWSubstantially EquivalentSybron Dental Specialtiesaccessdata.fda.gov
April 20, 2012K120037BLUWHITE DIAMOND DENTAL BURS MODIFIEDDZPSubstantially EquivalentBeavers Dental, Div. Sybron Canada, Ltd.accessdata.fda.gov
April 8, 2011K110092TAKE 1 ADVANCED RIGID TRAYELWSubstantially EquivalentKerr Corporationaccessdata.fda.gov
January 20, 2011K103351DMC COMPOSITE 2EBFSubstantially EquivalentKerr Corporationaccessdata.fda.gov
April 3, 2009K090292PREMISE MODIFIEDEBFSubstantially EquivalentKerr Corp.accessdata.fda.gov
December 11, 2008K082671HERCULITE ULTRAEBFSubstantially EquivalentSybron Dental Specialtiesaccessdata.fda.gov
October 19, 2006K062519NEXUS 3EMASubstantially EquivalentKerr Corporationaccessdata.fda.gov
May 10, 2006K060698CEMENT-IT ALL PURPOSE, MODEL N97EMASubstantially EquivalentPentron Clinical Technologiesaccessdata.fda.gov
March 28, 2006K060469OPTIBOND ALL-IN-ONEKLESubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
February 3, 2006K053565TEMPBOND CLEAR WITH TRICLOSANEMASubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
April 15, 2005K050604KERR VPS IMPRESSION MATERIALELWSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
July 2, 2003K031444OPTIBOND FLKLESubstantially EquivalentKerr Dental Materials Centeraccessdata.fda.gov
August 1, 2002K021457FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIALEBGSubstantially EquivalentPentron Corp.accessdata.fda.gov
January 16, 2002K013647REVOLUTION FORMULA 2EBFSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
September 4, 2001K012405EXTRUDE MODIFIEDELWSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
April 23, 2001K010994TAKE ONE BITE MODIFIEDELWSubstantially EquivalentKerr Corp.accessdata.fda.gov
February 15, 2001K003650PERMLASTIC 3ELWSubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
January 4, 2001K003658TEMP-BOND NE 2EMASubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
March 17, 2000K000211BUILD-IT FREBFSubstantially EquivalentJeneric/Pentron, Inc.accessdata.fda.gov
July 9, 1999K991808OPTIBOND SOLO PLUS 2KLESubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
November 9, 1998K983266FIBREKOR POST SYSTEMELRSubstantially EquivalentJeneric/Pentron, Inc.accessdata.fda.gov
October 30, 1995K954708SILANE PRIMERKLESubstantially EquivalentSybron Dental Specialties, Inc.accessdata.fda.gov
August 28, 1995K952662COMP=FLOWEBFSubstantially EquivalentJeneric/Pentron, Inc.accessdata.fda.gov
May 23, 1995K951238SAFE-TIPS EZEIASubstantially EquivalentSafe Wave Products, Inc.accessdata.fda.gov
April 14, 1981K810825POLYVINYL SILICONE IMPRESSION MATERIALELWSubstantially EquivalentDental-Material Gesellschaftaccessdata.fda.gov

Compare with other makers

Updated January 12, 2023. 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.