Denti-Care Denti-Rinse
Sodium Fluoride
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9611959 | 3002677549 | AMD Medicom Inc. | 1 | N | 2026-01-01 | 2555 Chemin de l'Aviation Pointe-Claire, Montreal Quebec CA H9P 2Z2 |
| 3012482820 | 3012482820 | AMD Medicom Inc. | 1 | Y | 2026-01-01 | 6054 Shook Road Suite 200 Lockbourne OH US 43137 |
| 3004024018 | 3004024018 | AMD MEDICOM INC. | 1 | Y | 2020-04-25 | 4049 Allen Station Road Augusta GA US 30906 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 20686864060943 | MEDICOM DENTICARE - Medicom DentiCare Spin DPA, Soft Cup - Gray | 1.800.361.2862 | mdasilva@medicom.ca |
| 20686864060950 | MEDICOM DENTICARE - Medicom DentiCare Spin DPA, Firm Cup - white | 1.800.361.2862 | mdasilva@medicom.ca |
| 20686864061643 | MEDICOM - MEDICOM SafeMask Signature - Procedure Earloop Facemask - Fog-Free - Blue - Level 3 | +1(514)636-6262 | zhusseiny@medicom.ca |
| 20686864061650 | MEDICOM - MEDICOM SafeMask Signature - Procedure Earloop Facemask - Fog-Free - Blue - Level 3 | +1(514)636-6262 | zhusseiny@medicom.ca |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 9574 | 1495926269 | K990719 | EARLOOP FACE MASK | FXX | 1999-07-12 |
| 9574 | 1683591722 | K953829 | SAFE-T-SEAL | KCT | 1995-11-09 |
| 9574 | 1054394975 | K931202 | STERILIZATION WRAP-STERISHEET | FRG | 1993-12-16 |
| 9574 | 1650224688 | K895077 | SURGICAL MASK/DENTAL MASK | FXX | 1989-11-03 |
| 9574 | 2018531170 | K830269 | FLORET NEURO SPONGE | EFQ | 1983-06-02 |
| 9574 | 1588095601 | K240950 | Disposable Prophy Angle | EGS | 2025-05-28 |
| 9574 | 1849054880 | K240862 | Medicom Sterilization Wrap | FRG | 2024-06-21 |
| 9574 | 1446022053 | K240629 | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl | LZA | 2024-05-28 |
| 9574 | 1308457935 | K222551 | Humask Pro Vision, Humask Pro Vision 3000 | FXX | 2022-11-10 |
| 9574 | 1392782796 | K221165 | Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl | LZA | 2022-11-20 |
| 9574 | 1460680607 | K212735 | Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) | LZA | 2022-01-11 |
| 9574 | 1353167491 | K212578 | Nitrile disposable examination gloves | LZA | 2021-12-02 |
| 9574 | 1089521925 | K202536 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate | LZA | 2021-08-11 |
| 9574 | 1522610050 | K200581 | Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | 2020-04-25 |
| 9574 | 1187534841 | K200019 | Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) | LZA | 2020-04-06 |
| 9574 | 1110532610 | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | FRC | 2019-09-13 |
| 9574 | 1984137499 | K190454 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff | LZA | 2019-09-26 |
| 9574 | 1144717680 | K190308 | Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) | OXZ | 2019-09-17 |
| 9574 | 1816180174 | K190306 | AMD Ritmed AssureWear VersaGown | FYC | 2020-01-17 |
| 9574 | 1172177496 | K182383 | Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue | LZC | 2019-03-19 |
| 9574 | 1619970966 | K182115 | Vinyl Patient Examination Gloves | LYZ | 2018-10-03 |
| 9574 | 1364581156 | K173196 | SUNTOUCH Dental Dressing | OLR | 2018-01-24 |
| 9574 | 1666625059 | K173137 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink) | LZA | 2017-12-12 |
| 9574 | 1125481536 | K171873 | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs | LZA | 2017-11-15 |
| 9574 | 1383181998 | K171823 | U&U Indicator tape and strip | JOJ | 2018-02-22 |
| 9574 | 1119147415 | K162923 | NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - AQUA BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - VIOLET BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK BLUE; NITRILE POWDER FREE EXAMINATION GLOVE TESTED FOR USE WITH CHEMOTHERAPY DRUGS - DARK VIOLET BLUE | LZA | 2017-02-06 |
| 9574 | 1876104166 | K162095 | Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue) | LZA | 2016-11-02 |
| 9574 | 2035066937 | K153334 | Oral-B 5% Sodium Fluoride Varnish | LBH | 2016-05-20 |
| 9574 | 1512725277 | K143247 | Powder Free Nitrile Examination Gloves, Nonsterile,(Blue,Black, and White Colored) | LZA | 2015-01-22 |
| 9574 | 1476989569 | K141412 | STERILUCENT SELF-SEAL STERILIZATION POUCH | FRG | 2014-12-03 |
| 9574 | 1897744921 | K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | LBH | 2014-09-22 |
| 9574 | 1082524396 | K132221 | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES | LYZ | 2014-01-31 |
| 9574 | 1943032866 | K112654 | POWDERFREE POLYISOPRENE SURGICAL GLOVES | KGO | 2012-02-17 |
| 9574 | 1874295921 | K102836 | BONASIL A+ IMPRESSION MATERIALS | ELW | 2011-01-13 |
| 9574 | 1548112513 | K093794 | SMART-READ EZTEST-STEAM SCBI AND TEST PACK | FRC | 2010-05-14 |
| 9574 | 1156723097 | K091652 | NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS | LZA | 2009-09-04 |
| 9574 | 1073215470 | K071886 | SELF SEAL STERILIZATION POUCH | FRG | 2007-12-27 |
| 9574 | 1391937738 | K070428 | MEDICOM SELF-SEALING STERILIZATION POUCH | KCT | 2007-07-17 |
| 9574 | 1762991227 | K051291 | NON-STERILE SURGICAL MASK | FXX | 2005-09-20 |
| 9574 | 2067124322 | K040607 | MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES | LZA | 2004-04-22 |
| 9574 | 1184916050 | K040098 | VARNISHAMERICA | LBH | 2004-02-04 |
| 9574 | 2068243918 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | EGS | 2003-04-14 |
| 9574 | 1669904861 | K030228 | POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES | KGO | 2003-03-14 |
| 9574 | 1333492402 | K020474 | MAKRITE TYPE N95 RESPIRATOR AND SURGICAL MASK MODEL 910-N95 | MSH | 2002-07-23 |
| 9574 | 1318898860 | ||||
| 9574 | 1442428259 | ||||
| 9574 | 1464711364 | ||||
| 9574 | 1555762436 | ||||
| 9574 | 1795280170 | ||||
| 9574 | 1861779633 | ||||
| 9574 | 2001222051 | ||||
| 9574 | 2007173039 | ||||
| 9574 | 1029136323 | ||||
| 9574 | 1029757631 | ||||
| 9574 | 1043418327 | ||||
| 9574 | 1052836127 | ||||
| 9574 | 1108633485 | ||||
| 9574 | 1180869482 | ||||
| 9574 | 1195782593 | ||||
| 9574 | 1227288654 | ||||
| 9574 | 1231899623 | ||||
| 9574 | 1258015785 | ||||
| 9574 | 1305593163 | ||||
| 9574 | 1325592511 | ||||
| 9574 | 1327158978 | ||||
| 9574 | 1333129017 | ||||
| 9574 | 1377612186 | ||||
| 9574 | 1401401066 | ||||
| 9574 | 1405338934 | ||||
| 9574 | 1423248928 | ||||
| 9574 | 1480015912 | ||||
| 9574 | 1575431524 | ||||
| 9574 | 1605543122 | ||||
| 9574 | 1606913601 | ||||
| 9574 | 1626228407 | ||||
| 9574 | 1650184320 | ||||
| 9574 | 1673499073 | ||||
| 9574 | 1777414302 | ||||
| 9574 | 1840808440 | ||||
| 9574 | 1866193894 | ||||
| 9574 | 1868790224 | ||||
| 9574 | 1899009724 | ||||
| 9574 | 1905245098 | ||||
| 9574 | 1936355946 | ||||
| 9574 | 1944484516 | ||||
| 9574 | 1961563047 | ||||
| 9574 | 1989689352 |
Sodium Fluoride
AMD Medicom Inc.
AMD Medicom, Inc.
2026-03-17
2026-03-17
2026-02-25
2026-02-25
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2025-11-20
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