Home Care Fluoride
Stannous Fluoride
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1049061 | 1049061 | DENTALEZ OF ALABAMA | 1 | N | 2026-01-01 | 2500 U.S. HIGHWAY 31 SOUTH BAY MINETTE AL US 36507 |
| 1413475 | 1413475 | DENTAL TECHNOLOGIES, INC. | 1 | N | 2026-01-01 | 6901 NORTH HAMLIN AVE. Lincolnwood IL US 60712 |
| 2024949 | 2024949 | DENTAMERICA | 1 | N | 2026-01-01 | 18688 SAN JOSE AVE City of Industry CA US 91748 |
| 2087119 | 3003078093 | DENTAL IMPLANT TECHNOLOGIES, INC. | 1 | Y | 2026-01-01 | 9414 E San Salvador Dr SCOTTSDALE AZ US 85258 |
| 2132821 | 3001237746 | Dental Health Products Incorporated | 1 | Y | 2026-01-01 | 2614 N Sugar Bush Rd New Franken WI US 54229 |
| 2435118 | 2435118 | DENTATUS USA LTD. | 1 | Y | 2026-01-01 | 50 Broadway Suite 10 Hawthorne NY US 10532 |
| 2520265 | 2520265 | DENTALEZ, INC., STARDENTAL DIVISION | 1 | N | 2026-01-01 | 1816 Colonial Village Ln Lancaster PA US 17601 |
| 2521672 | 2521672 | Dentaurum Inc. | 1 | Y | 2026-01-01 | 2050 Cabot Boulevard West Suite 100 Langhorne PA US 19047 |
| 8030870 | 3006944200 | DENTATUS AB | 1 | N | 2026-01-01 | Finspangsgatan 42 SPANGA Stockholm SE SE-163 53 |
| 3000171384 | 3000171384 | DENTAL PROSTHETIC SERVICES, INC. | 1 | Y | 2026-01-01 | 1900 51st St NE CEDAR RAPIDS IA US 52402 |
| 3001389926 | 3001389926 | DENTAL MANUFACTURING SPA | 1 | N | 2026-01-01 | Via Ca Mignola Nuova, 1699 Badia Polesine Rovigo IT 45021 |
| 3004036186 | 3004036186 | DENTAL CRAFTERS | 1 | N | 2026-01-01 | 1000 Corporate Drive Marshfield WI US 54449 |
| 3004540219 | 3004540219 | DENTALIUM DENTAL CERAMICS, INC. dba SMITH STERLING DENTAL LABORATORIES | 1 | Y | 2026-01-01 | 8250 Nw 27th St Ste 307 Doral FL US 33122 |
| 3005575066 | 3005575066 | DentalWorx / LTD Dental Lab | 1 | Y | 2026-01-01 | 3830 Park Avenue Suite 201 Edison NJ US 08820 |
| 3005666189 | 3005666189 | DENTAZON CORPORATION | 1 | Y | 2026-01-01 | 24414 Main St Ste 203 Carson CA US 90745 |
| 3005720378 | 3005720378 | DENTALLE, INC. | 1 | Y | 2026-01-01 | 20283 SR 7 Suite 103 BOCA RATON FL US 33498 |
| 3005735859 | 3005735859 | DENTALL, INC. | 1 | N | 2026-01-01 | THE STANDARD WORKSHOP,TIAN-ZHU EXPORT PROCESSING AREA,SHUN YI DISTRICT, BEIJING CN 101312 |
| 3006945044 | 3006945044 | Dental Wings Inc. | 1 | N | 2026-01-01 | 160 Rue Saint-Viateur E Montreal Quebec CA H2T 1A8 |
| 3007830670 | 3007830670 | DENTALREE.COM | 1 | Y | 2026-01-01 | 10015 Sky Parlor Rd Las Vegas NV US 89178 |
| 3008347275 | 3008347275 | Dental Direkt GmbH | 1 | N | 2026-01-01 | Industriezentrum 106-108 Spenge North Rhine-Westphalia DE 32139 |
| 3008555159 | 3008555159 | DENTAL QUEST LABORATORY INC. | 1 | Y | 2026-01-01 | 495 Kings Hwy Valley Cottage NY US 10989 |
| 3009074216 | 3009074216 | DENTAL SAVINGS CLUB INC. | 1 | N | 2026-01-01 | 31 serge garant Verdun Quebec CA H3E0A6 |
| 3009165539 | 3009165539 | DENTAL BRANDS FOR LESS | 1 | Y | 2026-01-01 | 2230 SW 70th Ave Unit 6&7 Davie FL US 33317 |
| 3009353240 | 3009353240 | DENTAPREG AMERICA INCORPORATED | 1 | Y | 2026-01-01 | 2198 Main St Sarasota FL US 34237 |
| 3009390544 | 3009390544 | DENTAC, LLC | 1 | Y | 2026-01-01 | 2735 Villa Creek Dr Ste 227 Dallas TX US 75234 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07290112280848 | Expansion tool EX-screw 6.35+wrench long-Assy - ET-1250EX | +97297660379 | info@pyramidion-is.com |
| 07290112280855 | Expansion tool EX-screw+wrench short - Assy - ET-1850EX | +97297660379 | info@pyramidion-is.com |
| 07290112280862 | Long Driver 1.25 - DL-125 | +97297660379 | info@pyramidion-is.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 31107 | 1123188437 | K993324 | CARBOCEM ZINC POLYCARBOXYLATE CEMENT | EMA | 1999-11-09 |
| 7599 | 1299002679 | K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | EBW | 1999-06-09 |
| 31107 | 1331630281 | K984503 | ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 | KLE | 1999-02-26 |
| 7599 | 1057841146 | K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | EGS | 1999-01-08 |
| 7599 | 1675732072 | K982593 | LUBE FREE AUTOCHUCK TURBINE WITH VORTEX AIR SEAL FOR USE WITH STAR DENTAL 430 SERIES LUBE FREE HIGH SPEED DENTAL HANDPIE | EFB | 1998-10-22 |
| 5015 | 1123878376 | K974704 | HYDROGUM | ELW | 1998-01-29 |
| 31107 | 2024333897 | K963922 | ALPHA-DENT ROOT CANAL SEALER & FILLER | KIF | 1996-12-06 |
| 7599 | 1297598003 | K962540 | E-TYPE CONTRA ANGLE NAC-E | EGS | 1996-09-12 |
| 31107 | 1833138431 | K960667 | CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE | EBF | 1996-07-02 |
| 31107 | 1629345303 | K960365 | ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) | KLE | 1996-03-28 |
| 31107 | 1787930312 | K960165 | ALPHA-DENT COMPOSITE SURFACE SEALANT | EBF | 1996-03-15 |
| 31107 | 1426344318 | K960122 | ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL | EBG | 1996-02-21 |
| 5015 | 1627248568 | K955759 | LITEX 680 | EBZ | 1996-01-02 |
| 31107 | 1980181461 | K955521 | ALPHA-DENT COPAL CAVITY VARNISH | LBH | 1996-01-24 |
| 31107 | 1500812581 | K955089 | ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT | EMA | 1995-12-13 |
| 5015 | 1012119844 | K954820 | SCALEX 800 | ELC | 1996-01-18 |
| 7599 | 1978481264 | K944271 | DENTAL OPERATIVE UNIT ACCESORIES | EIA | 1994-12-29 |
| 31107 | 1591476141 | K942596 | ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT | EMA | 1994-06-16 |
| 31107 | 1486829338 | K940120 | ALPHA-DENT | ELW | 1994-02-25 |
| 31107 | 1599685691 | K935625 | ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM WITH FLUORIDE | DYH | 1994-08-10 |
| 31107 | 1040207832 | K935436 | ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED | EMA | 1994-06-10 |
| 31107 | 1772611428 | K932886 | ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE | EBF | 1993-09-29 |
| 31107 | 1216586907 | K932827 | ALPHA-DENT CORE BUILDUP PASTE | EBF | 1993-09-23 |
| 7597 | 2017457969 | K931204 | AS3000 OPERATIVE DENTAL UNIT (DELIVERY SYSTEM) | EIA | 1993-07-08 |
| 31107 | 2004654052 | K930614 | ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST | DYH | 1993-06-17 |
| 9186 | 1087909730 | K924805 | ORTHODONTIC ARCH WIRE | DZC | 1993-03-31 |
| 31107 | 1935877423 | K924635 | ALPHA-DENT PIT AND FISSURE SEALANT | EBC | 1992-10-16 |
| 9186 | 1978745360 | K923838 | THE ULTIMATE RCS ARCH WIRE | DZC | 1992-12-04 |
| 9186 | 1561635619 | K923837 | DIMPLED MULTI MODULUS ARCH WIRE | DZC | 1993-03-31 |
| 9186 | 1684727529 | K923836 | .016' X .016 NICKEL TITANIUM UPRIGHTING SPRING | DZC | 1992-12-23 |
| 31107 | 1764258354 | K921044 | ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND | DYH | 1992-11-09 |
| 31107 | 1525784940 | K904813 | VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. | EBF | 1991-05-31 |
| 31107 | 1435074380 | K904812 | COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE | EBF | 1991-02-26 |
| 7599 | 1376842551 | K896361 | HANDPIECE FIBER OPTIC SYSTEM IMPROVEMENT FEATURE | EFB | 1990-02-02 |
| 7599 | 1194356770 | K881253 | ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW | ELC | 1988-04-21 |
| 31107 | 1951108845 | K870579 | ALPHA-DENT PIT AND FISSURE SEALANT | EBC | 1987-03-02 |
| 31107 | 1006225445 | K790596 | ENAMEL BOND SYSTEM | EBC | 1979-06-15 |
| 31107 | 1162304092 | K790595 | DENTAL ALGINATE IMPRESSION MATERIAL | ELW | 1979-06-15 |
| 31107 | 1715877651 | K790593 | DENTAL CEMENT, ZINC PHOSPHATE | EMA | 1979-06-15 |
| 31107 | 1415695204 | K790592 | IMPRESSION MATERIAL, RUBBER | ELW | 1979-06-15 |
| 7599 | 1809421497 | K251701 | Star E900 Electric System | EBW | 2026-01-12 |
| 116196 | 1986529780 | K241579 | DD Hybridlayer (multicolored zirconia) | EIH | 2024-09-06 |
| 7599 | 1646881047 | K240183 | Star E900 Handpiece Series | EGS | 2024-09-19 |
| 297273 | 1083225247 | K233252 | Straumann CARES Visual and Nova Dental CAD | PNP | 2024-12-26 |
| 116196 | 1166325658 | K230410 | DD medical polymers (PMMA) | EBI | 2023-06-23 |
| 116196 | 1051265689 | K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | NHA | 2023-04-25 |
| 236196 | 1975203318 | K211415 | GR Splint Resin System | MQC | 2021-10-21 |
| 236196 | 1027797715 | K210298 | GR-14 Resin System | EBI | 2021-05-05 |
| 236196 | 1180280636 | K201827 | GR-17 Resin System | EBG | 2020-11-05 |
| 19533 | 1313155393 | K200623 | OssGuide | NPL | 2020-10-02 |
| 116196 | 2008369528 | K193588 | DD Contrast | EIH | 2020-04-16 |
| 7599 | 2047614850 | K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece | EFB | 2020-01-06 |
| 116196 | 1307848955 | K191111 | DD Solid Connect® CAD/CAM Abutments | NHA | 2023-01-11 |
| 116196 | 1716421280 | K183569 | DD cube ONE ML | EIH | 2019-02-14 |
| 7599 | 1374785597 | K182999 | General Cutting Contra Handpiece | EGS | 2019-04-16 |
| 116196 | 1003007245 | K170885 | DD cubeX2 HS | EIH | 2017-08-01 |
| 108702 | 1649943372 | K170588 | DESS Dental Smart Solutions | NHA | 2017-08-08 |
| 7599 | 1556359463 | K163483 | PANA SPRAY Plus | EFB | 2017-08-15 |
| 108702 | 1242497690 | K160581 | K3PRO Konus Additional Abutments and Implants | DZE | 2017-03-24 |
| 190140 | 1352822045 | K160410 | WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head | EFB | 2016-09-29 |
| 116196 | 2002859262 | K153490 | DD medical polymers | EBG | 2016-05-13 |
| 7599 | 1168341481 | K153411 | 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece | EFB | 2016-04-08 |
| 108702 | 1188744588 | K151295 | Biodenta Customized Abutment - Titanium | NHA | 2015-12-01 |
| 7599 | 1093613632 | K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | PEM | 2016-03-03 |
| 116196 | 2023508533 | K150196 | DD cubeX2 | EIH | 2015-03-26 |
| 116196 | 1763890886 | K143071 | Nacera Pearl | EIH | 2015-06-26 |
| 116196 | 1667020590 | K142987 | DD Bio Z, DD Bio ZX(square), DD BioZX(square) color | EIH | 2015-02-11 |
| 7599 | 1284109472 | K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | EGS | 2014-01-31 |
| 190140 | 1404138880 | K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | EGS | 2014-01-31 |
| 7599 | 1389867859 | K131578 | IPROPHY MOBILE | EKX | 2013-09-12 |
| 7599 | 1077978474 | K130455 | 430 SWL 45 AND 430 SW 45 HIGH-SPEED HANDPIECES | EFB | 2013-09-25 |
| 31107 | 1816137594 | K124025 | ALPHA-PRO WHITE VARNISH | LBH | 2013-09-18 |
| 5015 | 1994909901 | K120106 | APIXIA DIGIREX DIGITAL DENTAL REDIOGRAPHY SYSTEM | MUH | 2012-05-07 |
| 7599 | 1798123634 | K113301 | CONCENPIECE,HIGH-SPEED HANDPIECE SERIES | EFB | 2012-01-23 |
| 68153 | 2059356792 | K113201 | NARVAL CC | LQZ | 2011-12-01 |
| 116196 | 1978401267 | K112967 | PMMA CAD/CAM DISC | EBG | 2012-08-28 |
| 116196 | 2046901558 | K093748 | DD BIO Z AND DD BIO Z - TRANSPA | EIH | 2010-02-24 |
| 5015 | 2019485090 | K092833 | ENDOMAX CORDLESS ENDODONTIC HANDPIECE | EKX | 2010-01-07 |
| 7599 | 1503873607 | K090937 | E-STATIS 40 SYSTEM | EBW | 2009-07-24 |
| 108702 | 1417375898 | K090911 | IST SNORING APPLIANCE | LQZ | 2009-09-11 |
| 7599 | 1972115875 | K090135 | TRIMIRA IDENTAFI 3000 | NXV | 2009-02-17 |
| 7599 | 1931345664 | K083252 | NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM | EBW | 2009-02-18 |
| 68153 | 1663000690 | K083209 | ACRYLIC HERBST SPLINT APPLIANCE | LRK | 2009-01-27 |
| 68153 | 1340690571 | K073004 | SOMNOMED BFLEX | LRK | 2008-01-30 |
| 7599 | 1729186265 | K070869 | PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 | EFB | 2007-06-15 |
| 31107 | 1258532876 | K070191 | ALPHA-CORE DC | EBF | 2007-03-07 |
| 5015 | 1462063883 | K060640 | DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM | EHD | 2006-04-24 |
| 68153 | 1701675376 | K050592 | SOMNOMED MAS RXA | LRK | 2005-07-12 |
| 10701 | 2000364692 | K042931 | TUF LINK SILICONE RELINER | EBI | 2004-12-08 |
| 10701 | 1039660790 | K040143 | MONORAIL | DZE | 2004-09-13 |
| 68153 | 1104109771 | K030440 | OASYS-ORAL AIRWAY SYSTEM | LRK | 2003-08-26 |
| 7597 | 1093941943 | ||||
| 25102 | 1182450903 | ||||
| 25102 | 1256916034 | ||||
| 25102 | 1330499525 | ||||
| 116196 | 1548795966 | ||||
| 7599 | 1607601668 | ||||
| 25102 | 1719579572 | ||||
| 25102 | 1747010371 | ||||
| 7597 | 1769750367 | ||||
| 7599 | 1842112862 | ||||
| 25102 | 1943633943 | ||||
| 7597 | 1964966396 | ||||
| 25102 | 2029642171 | ||||
| 5015 | 1002607328 | ||||
| 31107 | 1005371683 | ||||
| 10701 | 1005419075 | ||||
| 92523 | 1007552998 | ||||
| 31107 | 1024269949 | ||||
| 10701 | 1044081879 | ||||
| 25102 | 1061261580 | ||||
| 68153 | 1061884606 | ||||
| 31107 | 1063751522 | ||||
| 133593 | 1072153955 | ||||
| 31107 | 1081141032 | ||||
| 31107 | 1092662775 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| EIH | 12 | 2024-09-06 |
| EFB | 9 | 2020-01-06 |
| EBF | 7 | 2007-03-07 |
| EGS | 6 | 2024-09-19 |
| EMA | 5 | 1999-11-09 |
| EBW | 4 | 2026-01-12 |
| NHA | 4 | 2023-04-25 |
| EBG | 4 | 2020-11-05 |
| LRK | 4 | 2009-01-27 |
| ELW | 4 | 1998-01-29 |
| DZC | 4 | 1993-03-31 |
| EBI | 3 | 2023-06-23 |
| DYH | 3 | 1994-08-10 |
| EBC | 3 | 1992-10-16 |
| DZE | 2 | 2017-03-24 |
| LBH | 2 | 2013-09-18 |
| EKX | 2 | 2013-09-12 |
| LQZ | 2 | 2011-12-01 |
| KLE | 2 | 1999-02-26 |
| ELC | 2 | 1996-01-18 |
| EIA | 2 | 1994-12-29 |
| PNP | 1 | 2024-12-26 |
| MQC | 1 | 2021-10-21 |
| NPL | 1 | 2020-10-02 |
| PEM | 1 | 2016-03-03 |
| MUH | 1 | 2012-05-07 |
| NXV | 1 | 2009-02-17 |
| EHD | 1 | 2006-04-24 |
| KIF | 1 | 1996-12-06 |
| EBZ | 1 | 1996-01-02 |
Stannous Fluoride
Stannous Fluoride
Stannous Fluoride
Stannous Fluoride
Sodium Fluoride and Hydrofluoric Acid
Sodium Fluoride and Hydrofluoric Acid
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Ethyl Alcohol 70%
1.5% Hydrogen Peroxide
sodium fluoride
sodium fluoride
Sodium fluoride
Sodium fluoride
sodium fluoride
Anticaries
Anticaries
Anticaries
Anticaries
Anticaries
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Benzocaine
Dentalmax Co., Ltd.
Dentalez, Inc., Stardental Division
Dental Direkt GmbH
Dental Imaging Technologies Corporation
Dental Direkt GmbH
Dental Direkt GmbH
Dental Direkt GmbH
Dental Choice Holdings LLC
DENTALMAX Co., Ltd.
Dental Evolutions Inc.
Dental Wings GmbH
Dental Direkt GmbH
DentalEZ, Inc.
Dental Choice Holdings, LLC
Dental Direkt GmbH
DenTack Implants Ltd
Dentalpoint AG
Dentalmax Co., Ltd
DentalEZ, Inc.
DENTALL Co., Ltd.
Dental Direkt GmbH
DENTALEZ, INC
DENTALIS BIO SOLUTION IMPLANTS LLC
DENTALPOINT AG
Dental Savings Club
DENTALPOINT AG
Dental Solutions, LLC
DENTAL DIREKT GMBH
DENTALEZ, INC.
Dentack Impants Ltd
DENTALPLUS GMBH
DENTAL EVOLUTIONS INC.
DENTALL CORPORATION
DENTAL DIREKT GMBH
DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT)
DENTALPOINT AG
DENTAL MORELLI
DENTALEZ GROUP, STARDENTAL DIVISION
DENTAL LABORATORY MILLING SUPPLIES LLC (DLMS)
DENTAL TECHNOLOGIES, INC.
2019-03-02
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2019-02-27
2019-02-26
2019-02-26