LFD

Product Code: LFD


Products Classified as LFD

1400Saliva, Artificial

Total Product Life Cycle (TPLC) Devices

1400Saliva, Artificial

FDA Consensus Standards

Saliva, Artificial [32309]21 CFR Unclassified 🔎

Pre-market Notifications for LFD

K202689Dentilube SprayOxy2plus, LLC
K201277Oral-B Dry Mouth Oral RinseThe Proctor & Gamble Company
K190144MucoPEGSunBio, Inc.
K181839CVS Health Dry Mouth Spray, OraLabs Dry Mouth SprayOraLabs, Inc.
K181194SmartMouth DryMouth Oral RinseTriumph Pharmaceuticals, Inc.
K181134G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral SpraySunstar Americas Inc
K180680Salivea Dry Mouth Mouthwash, Salivea Dry Mouth MouthsprayLaclede, Inc.
K173808Voutiaâ„¢Jeffrey Ward Cash, DDS
K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral MistSyendgen, Inc.
K171542TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (dba TheraBreath
K163476LubricityYou First Services, Incorporated
K163029Hydrisâ„¢ Oral RinseBIOPHARM CONSULT, L.L.C.
K162167Caphosol Artifical Saliva TabletsEUSA Pharma (UK) Limited
K152406SalivaMAXFORWARD SCIENCE LLC
K152201MedActive Oral Gel And SprayMedActive Oral Pharmaceuticals, LLC.

Global Unique Device Identification Database

00370275629306Saliva, Artificial
00370275629122Saliva, Artificial
00370275629030Saliva, Artificial
30348878600030SALIVA, ARTIFICIAL
50348878600027SALIVA, ARTIFICIAL
50348878600010SALIVA, ARTIFICIAL
00852181005059Saliva, Artificial
00852181005042Saliva, Artificial
00852181005141Saliva, Artificial
00852181005134Saliva, Artificial
00852181005097Saliva, Artificial
00858290006635Saliva, Artificial
00858290006666Saliva, Artificial
00864206000123Saliva, Artificial
00864206000109Saliva, Artificial

Maude Adverse Events

BIOTENE ORAL RINSE (UNSPECIFIED VARIANT)KIK CUSTOM PRODUCTS2020-02-03
BIOTENE MOISTURIZING MOUTH SPRAYULTRADENT PRODUCTS INC/ORATECH LLC2020-01-20
BIOTENE MOUTH SPRAY (UNKNOWN)ULTRADENT PRODUCTS INC/ORATECH LLC2020-01-15
BIOTENE MOISTURIZING MOUTH SPRAYULTRADENT PRODUCTS INC/ORATECH LLC2020-01-13
BIOTENE MOUTH SPRAY (ORIGINAL)ULTRADENT PRODUCTS INC/ORATECH LLC2019-11-07
BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)ULTRADENT PRODUCTS INC/ORATECH LLC2019-10-16
BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)KIK CUSTOM PRODUCTS2019-10-16
BIOTENEULTRADENT PRODUCTS INC/ORATECH LLC2019-10-16
BIOTENE ORAL RINSE (UNSPECIFIED VARIANT) (GLYCERIN) MOUTH WASHGLAXOSMITHKLINE2019-10-11
BIOTENE ORAL BALANCE GEL (GLYCERIN) GELGLAXOSMITHKLINE2019-10-11
BIOTENE DRY MOUTH LOZENGES (GLYCEROL, PECTIN) LOZENGEGLAXOSMITHKLINE2019-10-11
BIOTENEULTRADENT PRODUCTS INC/ORATECH LLC2019-10-09
BIOTENEULTRADENT PRODUCTS INC/ORATECH LLC2019-10-01
BIOTENE ORAL BALANCE GELULTRADENT PRODUCTS INC/ORATECH LLC2019-10-01
BIOTENE MOUTHWASH (2013 FORMULATION)KIK CUSTOM PRODUCTS2019-09-13
BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)ULTRADENT PRODUCTS INC/ORATECH LLC2019-08-28
BIOTENE DRY MOUTHGLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC2019-08-19
EQUATE BIOTENE DRY MOUTH ORAL RINSEUNK2019-08-09
BIOTENE MOUTH SPRAY (SAVANNAH)ULTRADENT PRODUCTS INC/ORATECH LLC2019-07-16
BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTIONKIK CUSTOM PRODUCTS2019-06-14
BIOTENE ORAL BALANCE GEL (AROMA)ULTRADENT PRODUCTS INC/ORATECH LLC2019-06-04
BIOTENE MOUTH SPRAY (ORIGINAL)ULTRADENT PRODUCTS INC/ORATECH LLC2019-05-08
BIOTENE MOUTH SPRAY (ORIGINAL)ULTRADENT PRODUCTS INC/ORATECH LLC2019-05-03
BIOTENE MOUTH SPRAY (UNKNOWN)ULTRADENT PRODUCTS INC/ORATECH LLC2019-04-29
BIOTENE ORIGINAL ORAL RINSE (SAVANNAH)KIK CUSTOM PRODUCTS2019-04-16
BIOTENE ORAL BALANCE GELULTRADENT PRODUCTS INC/ORATECH LLC2019-04-16
BIOTENEULTRADENT PRODUCTS INC/ORATECH LLC2019-04-10
BIOTENEULTRADENT PRODUCTS INC/ORATECH LLC2019-04-10
BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)ULTRADENT PRODUCTS INC/ORATECH LLC2019-04-01
BIOTENE MOUTH SPRAY (SAVANNAH)ULTRADENT PRODUCTS INC/ORATECH LLC2019-03-25
BIOTENE MOISTURIZING MOUTH SPRAY (2013 FORMULATION)ULTRADENT PRODUCTS INC/ORATECH LLC2019-03-25
BIOTENE MOUTH SPRAY (SAVANNAH)ULTRADENT PRODUCTS INC/ORATECH LLC2019-03-22
BIOTENE ORAL BALANCE GEL (AROMA)ULTRADENT PRODUCTS INC/ORATECH LLC2019-03-14
BIOTENE MOUTH SPRAY (SAVANNAH)ULTRADENT PRODUCTS INC/ORATECH LLC2019-03-14
BIOTENE MOUTHWASH (2013 FORMULATION)KIK CUSTOM PRODUCTS2019-03-05
BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)KIK CUSTOM PRODUCTS2019-02-15
BIOTENE DRY MOUTH ORAL RINSEGLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC2019-02-01
BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)KIK CUSTOM PRODUCTS2019-01-30
BIOTENEULTRADENT PRODUCTS INC/ORATECH LLC2019-01-25
BIOTENE ORAL RINSE (UNSPECIFIED VARIANT)KIK CUSTOM PRODUCTS2019-01-04
BIOTENE MOUTH SPRAY (ORIGINAL)ULTRADENT PRODUCTS INC/ORATECH LLC2019-01-04
BIOTENEULTRADENT PRODUCTS INC/ORATECH LLC2019-01-03
BIOTENE MOUTH SPRAY (ORIGINAL)ULTRADENT PRODUCTS INC/ORATECH LLC2019-01-02
BIOTENE GELULTRADENT PRODUCTS INC/ORATECH LLC2019-01-02
BIOTENE ORIGINAL ORAL RINSE (ORIGINAL)KIK CUSTOM PRODUCTS2018-12-20
BIOTENE DRY MOUTH GENTLE ORAL RINSE MILD MINT SOLUTIONKIK CUSTOM PRODUCTS2018-12-17
BIOTENE ORAL RINSE (UNSPECIFIED VARIANT)KIK CUSTOM PRODUCTS2018-12-10
CAPHOSOLEUSA PHARMA (US) LLC2018-12-04
BIOTENE MOUTH SPRAY (ORIGINAL)ULTRADENT PRODUCTS INC/ORATECH LLC2018-11-26
BIOTENE MOUTHWASH (2013 FORMULATION)KIK CUSTOM PRODUCTS2018-11-13
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