FDA.reportPublic FDA data

DENTSPLY PROSTHETICS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
25851142585114DENTSPLY PROSTHETICS1Y2020-04-25570 WEST COLLEGE AVENUE York PA US 17401

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
75431758953632K992956LUCITONE FRS FLEXIBEL DENTAL RESINEBI1999-10-06
75431502276165K984427EXCELSIOR PORCELAIN SYSTEMEIH1999-03-15
75431493129429K972573LIQCRYLIC PRO DENTAL RESINEBI1997-09-16
75431792888680K964040TRUBYTE SOFT RELINE SYSTEMEBI1996-12-06
75431085693374K940252FINESSE PORCELAIN SYSTEMEIH1994-03-01
75431098640529K933468MYERSON'S PERMASOFT SOFT RELINE MATERIALEBI1994-01-05
75431420981849K926406DUAL CURE RELINE MATERIALEBI1993-03-31
75431821279450K926347DUCERANIUM UEJH1993-05-27
75431889211929K923979LC TRAY MATERIALEBH1992-11-17
75431391516731K920499SANI-TIPECB1992-05-03
75432068605204K915543NEW OPAQUE PORCELAINEIH1992-03-19
75431586080366K905702NEW TRIAD TRANSHEET DENTURE BASE MATERIALEBI1991-04-29
75432001564877K904695GDC-1501EJT1991-01-02
75431090959526K900393OPAQUE PORCELAINEIH1990-04-16
75431540458723K882482TRIAD ORTHODONTIC GELEBI1988-08-12
75431421977961K854042RESIN TRAY IMPRESSION MATERIALEBH1985-11-07
75431119185605K834409DENTURE BASE RESINEBI1984-02-27
75431100399472K831647DENTURE RELINING, REPAIR/REBASING RESINEBI1983-06-30
75431086772032K803310CERAMCO PORCELAINEIH1981-01-14
75431155972828K191427Halley resin systemEBI2019-08-26
75431516169382K190043Halley resinEBI2019-04-24
75431241188604K182422Lucitone Denture Base MaterialsEBI2018-12-18
75431515679979K161330Pour AcrylicEBI2016-10-06
75431343158698K161269CELTRA PressEIH2016-08-12
75431224505457K160232Disposable Barrier Sleeves and CoversPEM2016-06-07
75431845671604K153590AvaDent Denture Base MaterialEBI2016-04-22
75432053711181K123615IRIS - HIGH STRENGTH GLASS CERAMICEIH2013-02-22
75431448728978K091706QUATTRO PORCELAIN SYSTEMEIH2009-08-28
75431338651268K080311MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEMEBG2008-04-18
75431788905595K072713ION DENTAL RESIN SYSTEMEBI2007-10-12
75431833929291K061580ECLIPSE WAX REMOVEREBI2006-07-28
75432024526624K061264TEMPFX ESTHETIC PROVISIONAL SYSTEMEBG2006-05-23
75431275862067K051707ECLIPSE BONDING AGENTKLE2005-07-15
75431370377196K041335PTM SYSTEMEIH2004-06-16
75432026695910K033553PFZ PORCELAIN SYSTEMEIH2003-12-02
75431623473988K032892MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEMEBI2003-09-26
75431379260477K022796CERCON CERAM S PORCELAINEIH2002-09-06
75431139770889K011560TRUBYTE DENTURE BASE RESIN SYSTEMEBI2001-07-12
75431038047394
75431090429418
75431121429972
75431235463921
75431270059518
75431572976946
75431605838732
75431674573742
75431691666886
75431704729770
75431731352728
75431754932124
75431791090541
75431840003839
75431936570130
75431977210300
75432003726547
75432018329748
75432062099427

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBI182019-08-26
EIH112016-08-12
EBG22008-04-18
EBH21992-11-17
PEM12016-06-07
KLE12005-07-15
EJH11993-05-27
ECB11992-05-03
EJT11991-01-02