FDA.reportPublic FDA data

DENTSPLY LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24244723002088145DENTSPLY LLC1Y2026-01-011301 SMILE WAY York PA US 17404
25153792515379DENTSPLY LLC1Y2026-01-0138 WEST CLARKE AVENUE MILFORD DE US 19963
30072691963007269196DENTSPLY LLC1N2020-04-25500 W. COLLEGE AVENUE York PA US 17404

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
75441040359432K992822SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINELBH1999-11-17
75481509453224K991909DELTON FS WITH FLUORIDE PIT & FISSURE SEALANTEBC1999-08-20
75481560336943K990703SPOROX II STERILIZING & DISINFECTING SOLUTIONMED1999-03-30
75481502276165K984427EXCELSIOR PORCELAIN SYSTEMEIH1999-03-15
75441045362083K984387R-30 AESTHETIC RESTORATIVEEBF1999-01-13
75441603936206K982395DYTRACT FLOW RESTORATIVEEBF1998-08-18
75441790955885K982394PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEMKLE1998-09-21
75441198939858K982318SPECTRUM 800 CURING UNITEBF1998-09-15
75481198939858K982318SPECTRUM 800 CURING UNITEBF1998-09-15
75441185323174K981965FLOWABLE COMPOSITEEMA1998-07-10
75441649662731K974140ADHESIVE HYBRID IONOMER CEMENTEMA1998-01-05
75441975999987K973781AQUASIL EASY MIX PUTTY IMPRESSION MATERIALELW1997-12-11
75441801272864K973221COMPOSITE 168 RESTORATIVE SYSTEMEBF1998-02-09
75441446606233K973201PROVI CEMENTEMA1998-06-05
75441493129429K972573LIQCRYLIC PRO DENTAL RESINEBI1997-09-16
75441132332149K972239ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTINGELW1997-08-01
75441744984527K972234RCT GEL ROOT CANAL THERAPY GELEIC1997-06-30
75441514117173K970433AQUASIL RIGID SMART WETTING IMPRESSION MATERIALELW1997-03-27
75481820104304K970342CAVITRON JET WITH SPS SYSTEMELC1997-04-04
75481782255906K970123DENTSPLY CAVITRON SPS SCALER SYSTEMELC1997-04-11
75441679596650K964525PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATORKLE1997-01-22
75481878811182K954802RITE-ANGLE DISPOSABLE PROPHY ANGLESEGS1995-11-08
75441985235356K951425SPECTRUM CURING LIGHT POLYMERIZATION UNITEBZ1995-05-05
75481985235356K951425SPECTRUM CURING LIGHT POLYMERIZATION UNITEBZ1995-05-05
75481891964734K951296DELTON F PIT & FISSURE SEALANTEBC1995-05-03
75441240237834K943574CAPTURE IMPRESSION MATERIALELW1994-08-23
75441114489442K942031CAULK TOOTH CONDITIONER GEL AND SYRINGEEBF1994-06-10
75481114489442K942031CAULK TOOTH CONDITIONER GEL AND SYRINGEEBF1994-06-10
75442066253665K941031TOHP-CAPFMI1995-01-26
75481085693374K940252FINESSE PORCELAIN SYSTEMEIH1994-03-01
75481346017525K933455COMPUTED ORAL RADIOLOGY SYSTEMEAP1994-01-31
75481940609362K932134RINN UNIVERSAL COLLIMATORIZX1993-07-26
75441723945984K930504NEW DENTIN PRIMERKLE1993-05-27
75441307383581K922721VLC DYCAL IIEJK1992-07-23
75481130690549K920758JENKER NEEDLE STICK PROTECTORDZM1992-04-28
75481391516731K920499SANI-TIPECB1992-05-03
75481335856132K903298DYNASONIC PLAQUE REMOVER & POLISHER DYNATIPELC1991-04-16
75481686020310K903163PERIODONTAL DEBRIDING SOLUTION EELC1990-10-10
75441686020310K903163PERIODONTAL DEBRIDING SOLUTION EELC1990-10-10
75481806549781K902413SONIC SCALERELC1990-08-13
75481090959526K900393OPAQUE PORCELAINEIH1990-04-16
75481674728287K900093DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIEREFB1990-04-06
75441279837218K896659SILANEKLE1990-02-14
75441484713676K896564DENTAL CORE MATERIALEBF1990-02-09
75441999401617K896341FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSUREEBC1990-04-23
75441118941708K883842DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.ELW1989-03-17
75441469005019K874945CEMENT LINEREMA1988-02-19
75441656237065K873153CAULK'S VPS CARTRIDGE SYSTEMEID1987-09-16
75441237572626K872251ABRASIVE DISC - POLISHING WHEELEJR1987-07-02
75481642622521K864996ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30ELC1987-02-19
75441329777197K864720LIGHT-CURED PERIODONTAL DRESSINGEMA1987-04-07
75441703240126K863552IMPROVED COMSPANEBF1986-10-17
75441314573847K863522MODIFIED SELF-CURE BONDING AGENTKLE1986-09-19
75441033569275K863288HYDROPHILIC REPROSILELW1986-12-01
75441397656484K863174CAULK'S POLISHING PASTEEBF1986-10-07
75441543373767K863092DENTAL COMPOSITE RESTORATIVEEBF1986-09-19
75441838386057K854253ROOT CANAL FILLING RESINKIF1985-12-16
75481934889882K842392DELTON * OPAQUE LIGHT CURING PITEBC1984-07-26
75481590634601K831380DELTON LIGHT CURING PIT & FISSUREEBC1983-06-30
75441610596550K820389A DENTAL AMALGAM ALLOY (UNNAMEDEJJ1982-03-11
75441617599111K812827ORBIC* SPHERICAL ALLOYEJJ1981-11-16
75481086772032K803310CERAMCO PORCELAINEIH1981-01-14
75441117591817K802967DISPERSALLOY-DISPERSED PHASE ALLOY SELF-DZS1980-12-30
75442001975691K802362ALGINATE IMPRESSION MATERIALELW1980-10-10
75441093204686K801690VALIANTEJJ1980-08-13
75441758157344K801142PALODENT MATRICES & BITINE RINGSDZN1980-08-07
2159741288406864K792445MW STRAIGHT ATTACHMENTEGS1979-12-06
75481288406864K792445MW STRAIGHT ATTACHMENTEGS1979-12-06
2159741218421444K792302LS-100EFB1979-11-27
75441990754542K792042DENTURE BASE RESINEBI1979-11-30
75481145411320K790935DELTON* PIT AND FISSURE SEALENTEBC1979-08-03
75441145411320K790935DELTON* PIT AND FISSURE SEALENTEBC1979-08-03
75441326313983K781151REPROSILELW1978-08-31
75441741541248K780384IMPROVED DYCALEJK1978-03-15
75441433626538K780301CAULK TYLOKEMA1978-02-28
75441941092128K760376CEMENT, RESIN DENTAL (SOLO-TACH)DYH1976-08-23
75481479320830K243336Lucitone Digital Print Denture™ SystemEBI2024-12-17
75441757084581K240888Calibra Abutment Resin CementEMA2024-04-02
75481989927295K231578Lucitone Digital Print Denture SystemEBI2023-10-20
75441807952126K191865SmartLite Pro Modular LED Curing LightEBZ2019-11-20
75481155972828K191427Halley resin systemEBI2019-08-26
75481516169382K190043Halley resinEBI2019-04-24
75481963942616K183018VPro5OYH2019-11-01
75481241188604K182422Lucitone Denture Base MaterialsEBI2018-12-18
75441681928319K181476Prime&Bond active Universal AdhesiveKLE2018-09-28
75441427916466K162107TPH Spectra+ Universal Composite RestorativeEBF2016-09-27
75481515679979K161330Pour AcrylicEBI2016-10-06
75481343158698K161269CELTRA PressEIH2016-08-12
75481995608861K160825MIDWEST RDH Freedom Cordless Prophy System with SmartMode TechnologyEKX2016-09-27
75481224505457K160232Disposable Barrier Sleeves and CoversPEM2016-06-07
75441224505457K160232Disposable Barrier Sleeves and CoversPEM2016-06-07
75441513847796K152861Aquasil Ultra + Smart Wetting Impression MaterialELW2016-03-04
75441229923930K151619Prime&Bond Elect Universal Dental AdhesiveKLE2015-10-30
75481264647301K150535Cavitron Touch Ultrasonic Scaling SystemELC2015-06-16
75481084775887K130862CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEMELC2013-07-23
75441878861836K123664INCORIS ZIEIH2013-04-08
75442053711181K123615IRIS - HIGH STRENGTH GLASS CERAMICEIH2013-02-22
75441557622179K123545INCORIS TZIEIH2013-02-01
75441533199693K123215VISCOSTAT CLEARMVL2013-02-05
75481788276711K122331CAVITY VARNISHLBH2012-10-15
75481267813368K121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINEJR2012-08-06
75441390706195K113406AQUASIL ULTRA SMART WETTING IMPRESSION MATERIALELW2012-02-13
75441415704870K113040CERAMIR CROWN & BRIDGEEMA2011-12-28
75481900249483K110768COMPUTED DENTAL RADIOGRAPHYMUH2011-04-20
75481454684996K110753MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEMEKX2011-06-06
75442045746424K102739HYDROCOLOR 5ELW2010-12-08
75441584678237K101710LUXATEMP ULTRA /STAREBG2010-09-28
75481216802856K093453MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEMEAP2009-11-30
75441448728978K091706QUATTRO PORCELAIN SYSTEMEIH2009-08-28
75481448728978K091706QUATTRO PORCELAIN SYSTEMEIH2009-08-28
75441044837115K083841ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIALEBF2009-04-14
75441057711694K083326FLUOROCORE 2EBF2009-02-10
75481529041821K082973STER-MATE STERILE LAVAGE KITELC2009-01-29
75441517716290K073173SELF-ADHESIVE RESIN CEMENTEMA2008-01-23
75441107616143K073117DENTIN DESENSITIZER AGENTLBH2007-12-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
ELW182016-03-04
EBF162016-09-27
KLE142018-09-28
ELC142015-06-16
EMA112024-04-02
EIH112016-08-12
EBI102024-12-17
EBC82005-05-11
EBG72010-09-28
EBZ42019-11-20
LBH42012-10-15
EGS42003-04-14
EJJ41982-03-11
LYC32007-08-08
EKX22016-09-27
PEM22016-06-07
EJR22012-08-06
MUH22011-04-20
EAP22009-11-30
EJK21992-07-23
EFB21990-04-06
OYH12019-11-01
MVL12013-02-05
FXX12006-08-14
JOJ12002-05-07
KOJ12002-03-15
MED11999-03-30
EIC11997-06-30
FMI11995-01-26
IZX11993-07-26
ECB11992-05-03
DZM11992-04-28
EID11987-09-16
KIF11985-12-16
DZS11980-12-30
DZN11980-08-07
DYH11976-08-23