FDA.reportPublic FDA data

Pamela Papineau

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80441643004150030Pamela Papineau1N2026-01-015 WHITCOMB AVENUE Ayer MA US 01432
30066945153006694515Pamela Papineau1N2026-01-015 WHITCOMB AVENUE Ayer MA US 01432
30090818303009081830Pamela Papineau1N2026-01-015 WHITCOMB AVENUE Ayer MA US 01432

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
136301941757057K992879ECUSIT COMPOSITE REPAIRKLE1999-11-09
731011363680238K992609HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400EBI1999-09-22
136301699814218K992609HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400EBI1999-09-22
731011110632296K984341STERNVANTAGE VARNISH LC, MODEL 221001EBI1999-01-08
136301797965316K984341STERNVANTAGE VARNISH LC, MODEL 221001EBI1999-01-08
136301892305140K982895STERNOMEGA COMPOMER CEMENTEMA1998-10-09
731011521152786K982692STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LCEBF1998-10-22
136301189783934K980018CRISTOBALEBF1998-05-19
731011463893297K980018CRISTOBALEBF1998-05-19
731011155779805K970774TEMPOCEM NE (MULTIPLE)EMA1997-06-03
136301959664290K970774TEMPOCEM NE (MULTIPLE)EMA1997-06-03
731011375489730K954867IONOSIT SEALEBC1996-03-08
136301480702131K954867IONOSIT SEALEBC1996-03-08
136301563202645K935689IONOSIT BASE LINEREBD1994-01-21
136301115017043K903481ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVEREBF1990-12-17
731012013001390K903481ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVEREBF1990-12-17
136301161386056K890464ZENITH 40% PHOSPHORIC ACID GELEBC1989-02-13
731011558906977K890464ZENITH 40% PHOSPHORIC ACID GELEBC1989-02-13
731011319638632K853055LIGHT CURE FILLING MATERIALEBF1985-11-19
136301904077063K853055LIGHT CURE FILLING MATERIALEBF1985-11-19
731011574084828K845034FOREMOST LITE CURE PIT & FISSURE SEALANTEBC1985-03-18
136301635404278K845034FOREMOST LITE CURE PIT & FISSURE SEALANTEBC1985-03-18
731011215087782K845033FOREMOST DENTIN ADHESIVEEBF1985-03-18
136301240025338K845033FOREMOST DENTIN ADHESIVEEBF1985-03-18
136301623081408K810825POLYVINYL SILICONE IMPRESSION MATERIALELW1981-04-14
731011840299164K810825POLYVINYL SILICONE IMPRESSION MATERIALELW1981-04-14
731011192960062K810813DMG-POLISHABLE COMPOSITEEBD1981-04-14
136302072170257K810813DMG-POLISHABLE COMPOSITEEBD1981-04-14
1596141415638267K251084zirkon; structure; LFU shades, stains and glazesEIH2025-06-05
136301463981563K213201DeltaFil, DeltaFil ConditionerEMA2022-06-01
136302014127434K183337LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2EBG2019-05-29
136301507531934K171772Ecosite Bulk FillEBF2018-01-31
1596141909181564K163228APVolution SystemEIH2017-06-05
136301385395283K160443TempoCem ClearEMA2016-09-30
731011513577368K160443TempoCem ClearEMA2016-09-30
1596141614235231K141400DCCERAM SYSTEMEIH2015-01-28
136301044926815K131248ETCH GELKLE2013-07-11
731011854351600K131248ETCH GELKLE2013-07-11
731011115319676K130580RETRACTION PASTEMVL2014-02-25
136301205878086K110759TEMPOCEMEMB2011-06-10
136301068371655K102603SA FLOWABLE ADHESIVEEBF2010-11-17
731011487734796K102603SA FLOWABLE ADHESIVEEBF2010-11-17
731011656487414K101710LUXATEMP ULTRA /STAREBG2010-09-28
136301786810467K101710LUXATEMP ULTRA /STAREBG2010-09-28
136301854746745K100062INFILTRATION KITEBC2010-03-26
136301450200656K093587DENTAL MERCURYELY2010-01-21
731011746753153K093587DENTAL MERCURYELY2010-01-21
731011222642382K093338SELF ADHESIVE COMPOSITE LUTING CEMENTEMA2010-02-12
136301287895215K093338SELF ADHESIVE COMPOSITE LUTING CEMENTEMA2010-02-12
731011109725807K080480NANOCOMPOSITE RESTORATIVE KITEBF2008-05-30
136301660057249K080480NANOCOMPOSITE RESTORATIVE KITEBF2008-05-30
731011292633752K080479DENTAL CERAMICEIH2008-05-21
136301532764235K080479DENTAL CERAMICEIH2008-05-21
136301975661569K063444TOTAL ETCH BONDING AGENTKLE2007-03-20
731011976130921K063444TOTAL ETCH BONDING AGENTKLE2007-03-20
136301362006231K052800PROVISIONAL INLAY/ONLAY KITEBG2006-03-07
731011252393123K041960COMPOSITE/COMPOMER REPAIR KITKLE2004-08-30
136301773951462K041960COMPOSITE/COMPOMER REPAIR KITKLE2004-08-30
136301061960942K033227LUXAFORM PLUSEBG2004-01-16
731011682415156K033227LUXAFORM PLUSEBG2004-01-16
731011081567113K023649VITIQUE SYSTEMEMA2003-01-17
136302039226226K023649VITIQUE SYSTEMEMA2003-01-17
136301357180234K013674LUXATEMP/LUXATEMP SOLAR/INSTATEMPEBG2002-01-24
731011814559117K013674LUXATEMP/LUXATEMP SOLAR/INSTATEMPEBG2002-01-24
136301298770794K013571MAGICFILEBF2002-01-17
136301058065134K013237STATUSBLUEELW2001-10-22
136301110970848K013236LUXABITEELW2001-10-17
136301244004877K013179LUXAGLAZEEBD2001-10-12
731011685535475K013179LUXAGLAZEEBD2001-10-12
136301375537447K012316PERMACEM / PERMACEM DUALEMA2001-08-23
136301822826212K012307LUXACORE/LUXACORE DUALEBF2001-08-23
731012025243416K012307LUXACORE/LUXACORE DUALEBF2001-08-23
136301032938394K011211FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOWEBF2001-06-18
731011948604325K011211FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOWEBF2001-06-18
731011004670974K000951LUXAFORMEBG2000-04-05
136302034261932K000951LUXAFORMEBG2000-04-05
136301790223053K000878HONIGUMELW2000-04-11
136301412465682
731011443256859
136301482585125
136301762954686
136301908451907
136301956527166
136302050143203
136301015127962
136301116055804
731011205821418
731011290382628
136301333385462
1596141340683178
1596141358025904
1596141358171634
136301497481368
731011497698875
136301560796904
136301627647791
1596141676815527
136301699634344
136301778795485
136302011127376
136302016393244
1596142059723554
731012064846215

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF192018-01-31
EMA112022-06-01
EBG102019-05-29
KLE72013-07-11
EBC72010-03-26
EIH52025-06-05
ELW52001-10-22
EBD52001-10-12
EBI41999-09-22
ELY22010-01-21
MVL12014-02-25
EMB12011-06-10