FDA 510(k) Applications for Medical Device Product Code "LFD"
(Saliva, Artificial)

FDA 510(k) Number Applicant Device Name Decision Date
K091718 BARTOR PHARMACAL CO., INC. NEUTRASAL 09/02/2009
K142657 BIO COSMETICS, S.L. XEROSTOM SALIVA SUBSTITUTE GEL 09/14/2015
K072306 BIO-X HEALTHCARE S.A. BIOXTRA MOISTURIZING GEL 11/15/2007
K120552 BIOCOSMETICS LABORATORIES AIR LIFT/XEROSTOM ARTIFICIAL SALIVA 06/06/2012
K163029 BIOPHARM CONSULT, L.L.C. HydrisÖ Oral Rinse 06/19/2017
K111250 DR. FRESH, INC. DRY MOUTH MOUTHWASH 04/27/2012
K171542 Dr. Harold Katz, LLC (dba TheraBreath TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges 03/16/2018
K150074 ELEVATE ORAL CARE Elevate Moisturizing Spray 06/19/2015
K162167 EUSA Pharma (UK) Limited Caphosol Artifical Saliva Tablets 03/31/2017
K152406 FORWARD SCIENCE LLC SalivaMAX 12/23/2015
K874106 FRESENIUS USA, INC. GLANDOSANE (SALIVART) SYNTHETIC SALIVA 04/15/1988
K101346 GC AMERICA, INC. GC ORAL MOISTURIZING GEL 01/27/2011
K981693 GEBAUER CO. SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 08/06/2001
K101477 GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH 09/28/2010
K103745 GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF 07/20/2011
K123731 GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY 01/04/2013
K041563 GLAXOSMITHKLINE CONSUMER HEALTHCARE, L.P. OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS 08/27/2004
K030802 INPHARMA A.S. CAPHOSOL 11/25/2003
K991938 INPHARMA A.S. CAPHOSOL ARTIFICIAL SALIVA 08/10/1999
K093642 INVADO PHARMACEUTICALS NEUTRASAL 12/11/2009
K142549 J.C.E.C. Company, Inc. (doing business as Fountain Health Ca Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste 05/26/2015
K173808 Jeffrey Ward Cash, DDS VoutiaÖ 07/27/2018
K810157 KINGSWOOD LABORATORIES, INC. MOI-STIR 02/10/1981
K851026 KINGSWOOD LABORATORIES, INC. MOI-STIR ORAL SWABSTICK(S) 05/21/1985
K840807 KINGSWOOD LABORATORIES, INC. THROAT MOI-STIR 05/25/1984
K051812 LABORATOIRES CARILENE S.A.S. TGO SPRAY 10/21/2005
K061331 LACLEDE, INC. ORAL BALANCE LIQUID/ GEL 07/25/2006
K110116 LORIN TECHNOLOGIES CORPORATION XEROS DRY MOUTH PUMP 04/08/2011
K152201 MedActive Oral Pharmaceuticals, LLC. MedActive Oral Gel and Spray 12/30/2015
K071617 ORAL BIOTECH ORAL NEUTRALIZER 10/19/2007
K062653 PARNELL PHARMACEUTICALS, INC. MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098 10/27/2006
K122663 QUANTUM, INC. ORAMOIST 05/30/2013
K822971 ROXANE LABORATORIES, INC. SALIVA SUBSTITUTE 11/16/1982
K024148 SINCLAIR PHARMACEUTICALS, LTD. SALINUM, ORCLAIR 09/15/2003
K181134 Sunstar Americas Inc GòUòM HYDRAL Dry Mouth Oral Gel, GòUòM HYDRAL Dry Mouth Oral Rinse, GòUòM HYDRAL Dry Mouth Oral Spray 07/13/2018
K173237 Syendgen, Inc. Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist 03/19/2018
K091419 THE PROCTER & GAMBLE CO. VICKS POWERSHOT DRY THROAT & MOUTH RELIEF 08/28/2009
K163476 You First Services, Incorporated Lubricity 05/10/2017


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