FDA.reportPublic FDA data

DENCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
DENTRONIC5N2026-01-011598 Washington Ave San Leandro CA US 94577
Dennis Bassett5N2026-01-01457 W Virginia Ave Punta Gorda FL US 33950
Dennis Ralph Briscoe5N2026-01-01149 E 200 N Providence UT US 84332
10362121036212Dentsply Sirona Orthodontics Inc.1Y2026-01-017290 26th Court East Sarasota FL US 34243
10490611049061DENTALEZ OF ALABAMA1N2026-01-012500 U.S. HIGHWAY 31 SOUTH BAY MINETTE AL US 36507
12228021000120733DENTSPLY IH Inc.1Y2026-01-01590 LINCOLN STREET Waltham MA US 02451
14134751413475DENTAL TECHNOLOGIES, INC.1N2026-01-016901 NORTH HAMLIN AVE. Lincolnwood IL US 60712
16499953001947560Dentsply Sirona Orthodontics Inc.1N2026-01-011125 E Campbell Rd Ste 100 RICHARDSON TX US 75081
17216471721647DENTONICS, INC.1N2026-01-012833 TOPHILL RD. MONROE NC US 28110
20189572018957DEN-MAT HOLDINGS, LLC1Y2026-01-011017 W Central Ave Lompoc CA US 93436
20249492024949DENTAMERICA1N2026-01-0118688 SAN JOSE AVE City of Industry CA US 91748
20273752027375DENT ZAR, INC.1N2026-01-0122156 Sherman Way, Unit B Canoga Park CA US 91303
20320063003029409DENOVO DENTAL INC1Y2026-01-015130 Commerce Drive Baldwin Park CA US 91706
20871193003078093DENTAL IMPLANT TECHNOLOGIES, INC.1Y2026-01-019414 E San Salvador Dr SCOTTSDALE AZ US 85258
21328213001237746Dental Health Products Incorporated1Y2026-01-012614 N Sugar Bush Rd New Franken WI US 54229
24244723002088145DENTSPLY LLC1Y2026-01-011301 SMILE WAY York PA US 17404
24351182435118DENTATUS USA LTD.1Y2026-01-0150 Broadway Suite 10 Hawthorne NY US 10532
25153792515379DENTSPLY LLC1Y2026-01-0138 WEST CLARKE AVENUE MILFORD DE US 19963
25202652520265DENTALEZ, INC., STARDENTAL DIVISION1N2026-01-011816 Colonial Village Ln Lancaster PA US 17601
25216722521672Dentaurum Inc.1Y2026-01-012050 Cabot Boulevard West Suite 100 Langhorne PA US 19047
29383862938386DenTek Oral Care, Inc.1Y2026-01-01660 white plains rd -- Tarrytown NY US 10591
80104715833Denise Case1N2026-01-01175 Freshwater Blvd Enfield CT US 06082
80106383004724816DENTSPLY DETREY GmbH1N2026-01-01DETREY STRASSE 1 KONSTANZ Baden-Wurttemberg DE 78467
80308703006944200DENTATUS AB1N2026-01-01Finspangsgatan 42 SPANGA Stockholm SE SE-163 53
80309033002913923Dennis Chandler1N2026-01-011643 North Alpine Road STE 104-803 Rockford IL US 61107

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
52141235491525K994224PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIALEBF2000-01-31
311071123188437K993324CARBOCEM ZINC POLYCARBOXYLATE CEMENTEMA1999-11-09
75441040359432K992822SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINELBH1999-11-17
339851427864555K992001TRAY-LINKELW1999-11-02
75481509453224K991909DELTON FS WITH FLUORIDE PIT & FISSURE SEALANTEBC1999-08-20
75991299002679K990954ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SETEBW1999-06-09
75481560336943K990703SPOROX II STERILIZING & DISINFECTING SOLUTIONMED1999-03-30
339851464572916K990108LC FLOWFILLEBF1999-03-09
52142015525309K990108LC FLOWFILLEBF1999-03-09
311071331630281K984503ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000KLE1999-02-26
339851432788257K984484LC MICROHYBRIDEBF1999-01-20
75481502276165K984427EXCELSIOR PORCELAIN SYSTEMEIH1999-03-15
75441045362083K984387R-30 AESTHETIC RESTORATIVEEBF1999-01-13
339851384576951K984097DC-COREEBF1999-02-09
75991057841146K983574STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTSEGS1999-01-08
75991675732072K982593LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIEEFB1998-10-22
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
339851829120225K981596ULTRAPAK EMVL1998-07-31
50151123878376K974704HYDROGUMELW1998-01-29
75441649662731K974140ADHESIVE HYBRID IONOMER CEMENTEMA1998-01-05
75441975999987K973781AQUASIL EASY MIX PUTTY IMPRESSION MATERIALELW1997-12-11
75441801272864K973221COMPOSITE 168 RESTORATIVE SYSTEMEBF1998-02-09
75441446606233K973201PROVI CEMENTEMA1998-06-05
52141566101064K973201PROVI CEMENTEMA1998-06-05
339852055748024K973201PROVI 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
339851273230083K964596PROSELECT 3 PERIDONTAL THERAPY SYSTEMELC1997-04-22
75441679596650K964525PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATORKLE1997-01-22
311072024333897K963922ALPHA-DENT ROOT CANAL SEALER & FILLERKIF1996-12-06
75991297598003K962540E-TYPE CONTRA ANGLE NAC-EEGS1996-09-12
52141148452707K962277SELF CURE BONDING AGENTKLE1996-07-03
52141264384787K960729ENAMEL CONDITIONER (ENAMEL ETCHING AGENT)EBF1996-04-26
311071833138431K960667CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDEEBF1996-07-02
52141596714071K960597ORION-1 VL CROWN BASE AND POST CEMENT VISIBLE LIGHT CUREEBF1996-04-26
52141239961495K960596ORION-I CORE BUILD-UP MATERIAL CHEMICAL CUREEBF1996-04-26
52141879462559K960595FANTASTIC 1 CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETSEBF1996-04-26
52141499278112K960594LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETSEBF1996-04-26
52142048782861K960565ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVEEBF1996-03-22
75711513539030K960548AH PLUS ROOT CANAL SEALERKIF1996-04-26
311071629345303K960365ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000)KLE1996-03-28
311071787930312K960165ALPHA-DENT COMPOSITE SURFACE SEALANTEBF1996-03-15
311071426344318K960122ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIALEBG1996-02-21
50151627248568K955759LITEX 680EBZ1996-01-02
311071980181461K955521ALPHA-DENT COPAL CAVITY VARNISHLBH1996-01-24
311071500812581K955089ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENTEMA1995-12-13
50151012119844K954820SCALEX 800ELC1996-01-18
75481878811182K954802RITE-ANGLE DISPOSABLE PROPHY ANGLESEGS1995-11-08
339851653868974K953504MICROPRIMEKLE1995-10-03
75441985235356K951425SPECTRUM CURING LIGHT POLYMERIZATION UNITEBZ1995-05-05
75481985235356K951425SPECTRUM CURING LIGHT POLYMERIZATION UNITEBZ1995-05-05
75481891964734K951296DELTON F PIT & FISSURE SEALANTEBC1995-05-03
339851181640540K951075S & C VINYL POLYSILOXANE IMPRESSION MATERIALELW1995-03-31
75991978481264K944271DENTAL OPERATIVE UNIT ACCESORIESEIA1994-12-29
75441240237834K943574CAPTURE IMPRESSION MATERIALELW1994-08-23
311071591476141K942596ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENTEMA1994-06-16
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
311071486829338K940120ALPHA-DENTELW1994-02-25
330781087518593K935727P&FS PIT AND FISSURE SEALANTEBC1994-01-21
330781163770340K935718JEDENTAL VLC DENTAL CURING LIGHTEAY1994-01-26
311071599685691K935625ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDEDYH1994-08-10
311071040207832K935436ALPHA-DENT GLASS IONOMER CEMENT, SELF CUREDEMA1994-06-10
330781005340988K934184FASTFILEMA1993-12-13
330781175849378K934073JEDENTAL GLASS IONOMER CEMENT AND LINEREMA1994-01-26
330781044472284K933656JEDENTAL PSROFILL SELF-CURE COMPOSITEEBF1993-11-17
330782020705715K933612JEDENTAL;PCA CEMENT (POLYCARBOXYLATE CEMENT)EMA1994-02-24
330781319900667K933543ZOE CEMENT (ZINC OXIDE & EUGENOL CEMENT)EMA1993-11-01
75481346017525K933455COMPUTED ORAL RADIOLOGY SYSTEMEAP1994-01-31
311071772611428K932886ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTEEBF1993-09-29
311071216586907K932827ALPHA-DENT CORE BUILDUP PASTEEBF1993-09-23
75481940609362K932134RINN UNIVERSAL COLLIMATORIZX1993-07-26
330781830182255K931880PROFILL LC COMPOSITEEBF1993-07-08
339851535103085K931867ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINEEBF1993-09-09
75972017457969K931204AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM)EIA1993-07-08
311072004654052K930614ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYSTDYH1993-06-17
75441723945984K930504NEW DENTIN PRIMERKLE1993-05-27
330781081629089K930248VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEMELW1994-01-07
91861087909730K924805ORTHODONTIC ARCH WIREDZC1993-03-31
311071935877423K924635ALPHA-DENT PIT AND FISSURE SEALANTEBC1992-10-16
91861978745360K923838THE ULTIMATE RCS ARCH WIREDZC1992-12-04
91861561635619K923837DIMPLED MULTI MODULUS ARCH WIREDZC1993-03-31
91861684727529K923836.016' X .016 NICKEL TITANIUM UPRIGHTING SPRINGDZC1992-12-23
75441307383581K922721VLC DYCAL IIEJK1992-07-23
1412391167972067K922499REFLECTIONS - CERAMIC DENTAL BRACKETEJF1992-07-30
311071764258354K921044ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BONDDYH1992-11-09
75481130690549K920758JENKER NEEDLE STICK PROTECTORDZM1992-04-28
75481391516731K920499SANI-TIPECB1992-05-03
311071525784940K904813VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.EBF1991-05-31
311071435074380K904812COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUEEBF1991-02-26
330782023846732K903551TEMPOREXEBF1990-10-05
75481335856132K903298DYNASONIC PLAQUE REMOVER & POLISHER DYNATIPELC1991-04-16
75441686020310K903163PERIODONTAL DEBRIDING SOLUTION EELC1990-10-10
75481686020310K903163PERIODONTAL 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
75991376842551K896361HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATUREEFB1990-02-02
75441999401617K896341FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSUREEBC1990-04-23
339851159777296K895731DEN-MAT CERINATE PORCELAINEIH1990-08-03
330781208852305K895386GLASIONEMA1990-04-16
339851579486173K895269DEN-MAT LAMI-QUICKELL1990-02-22
52141391937638K894639SKYROCK AND LIGHT SUPERBONDDYH1989-10-20
330781069769254K884081INTERIM, TEMPORARY CEMENTEMA1988-12-02
75441118941708K883842DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.ELW1989-03-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF582024-10-15
NHA422025-12-09
ELW372023-04-27
EMA322024-04-02
KLE282022-08-09
ELC182015-06-16
EBC152005-05-11
EIH142025-08-25
EBG142012-12-27
EBI112024-12-17
EFB102020-01-06
EBZ92019-11-20
LBH92013-09-18
DYH92001-10-24
EGS82024-09-19
OBR72020-12-22
NXC62026-04-15
GEX62014-07-25
DZE62013-10-25
KIF52025-02-13
EKX52016-09-27
EJR52012-08-06
EBW42026-01-12
PEM42016-06-07
NXV42009-02-17
DZC41993-03-31
EJJ41982-03-11
MUH32012-05-07
LYC32007-08-08
EIA32000-11-16
MVL22013-02-05
EAP22009-11-30
NJM22009-03-20
MQC22007-11-16
KOJ22002-03-15
EJK21992-07-23
DZN21980-08-07
PNN12026-03-04
NPL12020-10-02
OYH12019-11-01

NDC#

Oxygen

Denman Services, Inc.

Oxygen

PROVENGE

Dendreon Pharmaceuticals LLC

sipuleucel-T

OXYGEN

Dennis Welding Supply, Inc.

OXYGEN

Alpha-Pro

Dental Technologies, Inc.

Sodium Fluoride and Hydrofluoric Acid

Alpha-Pro

Dental Technologies, Inc.

Sodium Fluoride and Hydrofluoric Acid

Fluoridex

DEN-MAT HOLDINGS, LLC

Stannous Fluoride Rinse

FLUORIDEX

DEN-MAT HOLDINGS, LLC.

Sodium Fluoride

FLUORIDEX

DEN-MAT HOLDINGS, LLC.

Sodium Fluoride

FLUORIDEX

DENT-MAT HOLDINGS, LLC.

Sodium Fluoride

FLUORIDEX

DENT-MAT HOLDINGS, LLC.

Sodium Fluoride

kids kare

DEN-MAT HOLDINGS, LLC.

Stannous Fluoride

Kids Kare

DEN-MAT HOLDINGS, LLC.

Sodium Fluoride

Gel 1100

Dental Alliance Holdings LLC

sodium fluoride

Gel 1100

Dental Alliance Holdings LLC

sodium fluoride

Gel 1100

Dental Alliance Holdings LLC

sodium fluoride

Oraqix

Dentsply Pharmaceutical

lidocaine and prilocaine

65 records. Showing 1-40. Next

PMN#

bright CT

2023-12-14

Dentium Co., Ltd (Ict Branch)

200 records. Showing 1-40. Next

Applications#

761485

DENALI THERAPEUTICS INC.