FDA.reportPublic FDA data

Dentsply Sirona Orthodontics Inc.

Matched from indexed company URL: DENTSPLY LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10362121036212Dentsply Sirona Orthodontics Inc.1Y2026-01-017290 26th Court East Sarasota FL US 34243
12228021000120733DENTSPLY IH Inc.1Y2026-01-01590 LINCOLN STREET Waltham MA US 02451
16499953001947560Dentsply Sirona Orthodontics Inc.1N2026-01-011125 E Campbell Rd Ste 100 RICHARDSON TX US 75081
24244723002088145DENTSPLY LLC1Y2026-01-011301 SMILE WAY York PA US 17404
25153792515379DENTSPLY LLC1Y2026-01-0138 WEST CLARKE AVENUE MILFORD DE US 19963
80106383004724816DENTSPLY DETREY GmbH1N2026-01-01DETREY STRASSE 1 KONSTANZ Baden-Wurttemberg DE 78467
80402883002806793DENTSPLY INDUSTRIA E COMERCIO LTDA1N2026-01-01RUA JOSE FRANCISCO DE SOUZA 1926 DISTRITO INDUSTRIAL PIRASSUNUNGA Sao Paulo BR 13633-412
30037564933003756493DENTSPLY INDUSTRIA E COMERCIO LTDA1N2026-01-01RUA CARLOS TASSONI 4521, GALPAO 01 DISTRITO INDUSTRIAL PIRASSUNUNGA Sao Paulo BR 13633-418
30048841503004884150DENTSPLY SIRONA INC1N2026-01-01221 W Philadelphia St Ste 60w York PA US 17401
30061867963006186796DENTSPLY NORTH AMERICA LLC1Y2026-01-011800 Cloister Drive Lancaster PA US 17601
30131116923013111692Dentsply Implants Manufacturing GmbH1N2026-01-01Rodenbacher Chaussee 4 Hanau Hesse DE 63457
30145367603014536760Dentsply North America LLC1Y2026-01-0113320B Ballantyne Corporate PL. Charlotte NC US 28277
20862113001586030Dentsply Sirona Orthodontics Inc.1Y2020-04-25280 AVENIDA CAMPILLO STE J CALEXICO CA US 92231
25851142585114DENTSPLY PROSTHETICS1Y2020-04-25570 WEST COLLEGE AVENUE York PA US 17401
30066388273006638827DENTSPLY Implants N.V.1N2020-04-25Kolonel Begaultlaan 1b Leuven BE 3012
30072691963007269196DENTSPLY LLC1N2020-04-25500 W. COLLEGE AVENUE York PA US 17404
30114892723011489272DENTSPLY LA Export1Y2020-04-25Urb. Cielo Dorado Village Calle Rubi #114 Alts De Cerro Gordo 3&4 PR US 00692

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
75431758953632K992956LUCITONE FRS FLEXIBEL DENTAL RESINEBI1999-10-06
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
75431502276165K984427EXCELSIOR PORCELAIN SYSTEMEIH1999-03-15
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
2121681839639092K981858ATLANTIS ABUTMENT AND ATLANTIS ABUTMENT SCREWDZE1999-03-22
75441649662731K974140ADHESIVE HYBRID IONOMER CEMENTEMA1998-01-05
75441975999987K973781AQUASIL EASY MIX PUTTY IMPRESSION MATERIALELW1997-12-11
75441801272864K973221COMPOSITE 168 RESTORATIVE SYSTEMEBF1998-02-09
75441446606233K973201PROVI CEMENTEMA1998-06-05
75431493129429K972573LIQCRYLIC PRO DENTAL RESINEBI1997-09-16
75441493129429K972573LIQCRYLIC PRO DENTAL RESINEBI1997-09-16
3457801624662197K972436T1 LINE DENTAL HANDPIECESEFB1997-09-22
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
3457801564124832K965238T1 CONTROL HIGH SPEED DENTAL HANDPIECEEFA1997-03-19
75441679596650K964525PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATORKLE1997-01-22
75431792888680K964040TRUBYTE SOFT RELINE SYSTEMEBI1996-12-06
75621633448648K963205ALGINMAX, ORTHOCHROMEELW1996-10-29
75711513539030K960548AH PLUS ROOT CANAL SEALERKIF1996-04-26
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
75431085693374K940252FINESSE PORCELAIN SYSTEMEIH1994-03-01
75481085693374K940252FINESSE PORCELAIN SYSTEMEIH1994-03-01
75431098640529K933468MYERSON'S PERMASOFT SOFT RELINE MATERIALEBI1994-01-05
75481346017525K933455COMPUTED ORAL RADIOLOGY SYSTEMEAP1994-01-31
75481940609362K932134RINN UNIVERSAL COLLIMATORIZX1993-07-26
75441723945984K930504NEW DENTIN PRIMERKLE1993-05-27
75431420981849K926406DUAL CURE RELINE MATERIALEBI1993-03-31
75431821279450K926347DUCERANIUM UEJH1993-05-27
75621930468652K924211EJECTORDYN1993-03-31
75431889211929K923979LC TRAY MATERIALEBH1992-11-17
75441307383581K922721VLC DYCAL IIEJK1992-07-23
75621167972067K922499REFLECTIONS - CERAMIC DENTAL BRACKETEJF1992-07-30
1412391167972067K922499REFLECTIONS - CERAMIC DENTAL BRACKETEJF1992-07-30
75481130690549K920758JENKER NEEDLE STICK PROTECTORDZM1992-04-28
75431391516731K920499SANI-TIPECB1992-05-03
75481391516731K920499SANI-TIPECB1992-05-03
75432068605204K915543NEW OPAQUE PORCELAINEIH1992-03-19
75431586080366K905702NEW TRIAD TRANSHEET DENTURE BASE MATERIALEBI1991-04-29
75432001564877K904695GDC-1501EJT1991-01-02
75481335856132K903298DYNASONIC PLAQUE REMOVER & POLISHER DYNATIPELC1991-04-16
75441686020310K903163PERIODONTAL DEBRIDING SOLUTION EELC1990-10-10
75481686020310K903163PERIODONTAL DEBRIDING SOLUTION EELC1990-10-10
75621068849943K902836MICROETCHERKOJ1990-11-20
75481806549781K902413SONIC SCALERELC1990-08-13
75431090959526K900393OPAQUE PORCELAINEIH1990-04-16
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
75622057750307K895521RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE)DYH1989-12-07
75441118941708K883842DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.ELW1989-03-17
75431540458723K882482TRIAD ORTHODONTIC GELEBI1988-08-12
75621540458723K882482TRIAD ORTHODONTIC GELEBI1988-08-12
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
75431421977961K854042RESIN TRAY IMPRESSION MATERIALEBH1985-11-07
75481934889882K842392DELTON * OPAQUE LIGHT CURING PITEBC1984-07-26
75431119185605K834409DENTURE BASE RESINEBI1984-02-27
75431100399472K831647DENTURE RELINING, REPAIR/REBASING RESINEBI1983-06-30
75481590634601K831380DELTON LIGHT CURING PIT & FISSUREEBC1983-06-30
75441610596550K820389A DENTAL AMALGAM ALLOY (UNNAMEDEJJ1982-03-11
75441617599111K812827ORBIC* SPHERICAL ALLOYEJJ1981-11-16
75431086772032K803310CERAMCO PORCELAINEIH1981-01-14
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
75481288406864K792445MW STRAIGHT ATTACHMENTEGS1979-12-06
2159741288406864K792445MW STRAIGHT ATTACHMENTEGS1979-12-06
2159741218421444K792302LS-100EFB1979-11-27
75441990754542K792042DENTURE BASE RESINEBI1979-11-30
75441145411320K790935DELTON* PIT AND FISSURE SEALENTEBC1979-08-03
75481145411320K790935DELTON* PIT AND FISSURE SEALENTEBC1979-08-03
75441326313983K781151REPROSILELW1978-08-31
75441741541248K780384IMPROVED DYCALEJK1978-03-15
75441433626538K780301CAULK TYLOKEMA1978-02-28
75711433626538K780301CAULK TYLOKEMA1978-02-28
75441941092128K760376CEMENT, RESIN DENTAL (SOLO-TACH)DYH1976-08-23
2367331938443510K260722SureSmile Aligner (ASSY500020)NXC2026-04-15
2367331684198045K253565SureSmile SoftwarePNN2026-03-04
2121681068881545K252343Atlantis® Abutments in TitaniumNHA2025-12-09
2121682061652889K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsNHA2025-11-21
3457801808190059K250771Primescan 2NTK2025-08-29
3457801966779089K250295Dentsply Sirona Titanium Bases systemNHA2025-04-30
2121681435569526K250081Atlantis® Abutments in TitaniumNHA2025-04-11
75711572531196K243546AH Plus Endodontic SealerKIF2025-02-13
75481479320830K243336Lucitone Digital Print Denture™ SystemEBI2024-12-17
75441757084581K240888Calibra Abutment Resin CementEMA2024-04-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHA472025-12-09
EBI292024-12-17
EIH262018-08-01
EBF222018-11-20
ELW222016-03-04
KLE192018-09-28
ELC162015-06-16
EMA142024-04-02
EBG112020-10-27
NXC102026-04-15
DZE92013-10-25
EBC82005-05-11
EBZ72019-11-20
NJM72016-08-26
EGS62015-07-02
EFB62014-05-30
OAS52020-06-22
LLZ52018-04-04
PEM42016-06-07
LBH42012-10-15
DYH42012-02-07
DYW42009-07-24
EJJ41982-03-11
KIF32025-02-13
MQC32023-10-12
NPL32022-07-18
GEX32018-03-08
EKX32016-09-27
EIA32015-07-24
LYC32007-08-08
PNN22026-03-04
EJR22012-08-06
MUH22011-04-20
EAP22009-11-30
EHD22008-12-23
KOJ22002-03-15
EBH21992-11-17
EJF21992-07-30
EJK21992-07-23
ECB21992-05-03

NDC#

PMN#

200 records. Showing 1-40. Next

Applications#

GUDID#

80 records. Showing 1-40. Next