FDA.reportPublic FDA data

Kerr Italia, S.r.l.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80209941000231788Kerr Italia, S.r.l.1N2026-01-01Via Passanti, 174 SCAFATI Salerno IT 84018

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
169691388384955K991808OPTIBOND SOLO PLUS 2KLE1999-07-09
169691080547800K983266FIBREKOR POST SYSTEMELR1998-11-09
169691406887263K954708SILANE PRIMERKLE1995-10-30
169691491902893K952662COMP=FLOWEBF1995-08-28
169691349518812K951238SAFE-TIPS EZEIA1995-05-23
169691910254281K810825POLYVINYL SILICONE IMPRESSION MATERIALELW1981-04-14
169691080632157K222830Rainbow 360KLE2023-01-12
169691713465672K221255SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowEBF2022-08-31
169691659474519K182162OptiBond eXTRa UniversalKLE2018-11-07
169691022243187K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/MaterialsMVL2017-08-08
169691754656108K162257P1145 Dental RestorativeEBF2016-11-07
169691627082146K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressKIF2016-07-27
169691153692828K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesKIF2016-04-14
169691118373774K152956Pulp Canal Sealer, Pulp Canal Sealer EWTKIF2016-05-06
169691648954633K151332Nexus Universal, Nexus Universal ChromaEMA2015-08-17
169691056618302K150559Life Fast Set, Life Regular SetEJK2015-06-19
169691612022140K143209SonicFill 2EBF2015-02-05
169691428213601K130869TAKE 1 ADVANCEELW2013-05-30
169691313374198K120037BLUWHITE DIAMOND DENTAL BURS MODIFIEDDZP2012-04-20
169691285729267K110092TAKE 1 ADVANCED RIGID TRAYELW2011-04-08
169691604022113K103351DMC COMPOSITE 2EBF2011-01-20
169691104422253K090292PREMISE MODIFIEDEBF2009-04-03
169691433466908K082671HERCULITE ULTRAEBF2008-12-11
169691316837837K062519NEXUS 3EMA2006-10-19
169691883094375K060698CEMENT-IT ALL PURPOSE, MODEL N97EMA2006-05-10
169692018891382K060469OPTIBOND ALL-IN-ONEKLE2006-03-28
169691796008524K053565TEMPBOND CLEAR WITH TRICLOSANEMA2006-02-03
169691331734303K050604KERR VPS IMPRESSION MATERIALELW2005-04-15
169691384115315K031444OPTIBOND FLKLE2003-07-02
169691877395118K021457FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIALEBG2002-08-01
169691736892188K013647REVOLUTION FORMULA 2EBF2002-01-16
169691253098455K012405EXTRUDE MODIFIEDELW2001-09-04
169691361284124K010994TAKE ONE BITE MODIFIEDELW2001-04-23
169691035315964K003658TEMP-BOND NE 2EMA2001-01-04
169691188559024K003650PERMLASTIC 3ELW2001-02-15
169691338723909K000211BUILD-IT FREBF2000-03-17
169691094649693
169691103802792
169691137683035
169691257205741
169691289196562
169691327524489
169691412300149
169691439944991
169691599150210
169691607541456
169691645327574
169691657352580
169691666722123
169691683362008
169691722359705
169691747684087
169691810376213
169691876679748
169691950341580
169691950635295
169692029594029

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF92022-08-31
ELW72013-05-30
KLE62023-01-12
EMA52015-08-17
KIF32016-07-27
MVL12017-08-08
EJK12015-06-19
DZP12012-04-20
EBG12002-08-01
ELR11998-11-09
EIA11995-05-23