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#

Oraqix

Dentsply Pharmaceutical

lidocaine and prilocaine

Xylocaine

Dentsply Pharmaceutical

Lidocaine Hydrochloride and Epinephrine Bitartrate

Xylocaine

Dentsply Pharmaceutical

Lidocaine Hydrochloride and Epinephrine Bitartrate

Polocaine

Dentsply Pharmaceutical

Mepivacaine Hydrochloride

Articadent

Dentsply Pharmaceutical

Articaine hydrochloride and Epinephrine Bitartrate

Articadent

Dentsply Pharmaceutical

Articaine hydrochloride and Epinephrine Bitartrate

PMN#

Axeos

2020-06-22

Dentsply Sirona

200 records. Showing 1-40. Next

Applications#

GUDID#

AH Plus Jet Endodontic Sealer Starter Kit - AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin. The double-barrel syringes with disposable mixing tips for intraoral use offer a more precise, convenient and faster procedure. AH Plus endodontic sealer functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.

Dentsply De Trey GmbH

2025-03-31

AH Plus Jet Endodontic Sealer Syringe Refill - AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin. The double-barrel syringes with disposable mixing tips for intraoral use offer a more precise, convenient and faster procedure. AH Plus endodontic sealer functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.

Dentsply De Trey GmbH

2025-03-31

AH Plus Jet Endodontic Sealer Syringe Refill - AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin. The double-barrel syringes with disposable mixing tips for intraoral use offer a more precise, convenient and faster procedure. AH Plus endodontic sealer functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.

Dentsply De Trey GmbH

2025-03-31

80 records. Showing 1-40. Next