FDA.reportPublic FDA data

DENCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
Dennis Bassett5N2026-01-01457 W Virginia Ave Punta Gorda FL US 33950
DENSOL USA LLC5Y2026-01-01799 Roosevelt Rd Bldg 4 Ste 317-J Glen Ellyn IL US 60137
Deniz Ozgulbas5N2026-01-01130 W Pleasant Ave Pmb 148 Maywood NJ US 07607
DENSOL INTERNATIONAL (PRIVATE) LIMITED5N2026-01-01Mughal Pura Road, P.O Gohad Pur Sialkot Punjab PK 51310
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

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
GXY12026-05-08
PNN12026-03-04
NPL12020-10-02

NDC#

65 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

Applications#