FDA.reportPublic FDA data

SalivaMAX

Primary DI
00370275629047
Brand
SalivaMAX
Company
Forward Science Technologies LLC
Model
SalivaMAX 30ct – 04 NDC
Device description
SalivaMAX is a supersaturated calcium phosphate powder that when dissolved in water, creates a solution with a high concentration of electrolytes similar to that of natural saliva. SalivaMAX is an artificial saliva that is used to relieve acute and chronic symptoms of xerostomia and mucositis.
Published
2024-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LFDSaliva, Artificial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFDSaliva, ArtificialUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152406000SalivaMAXForward Science, LLC2015-12-23LFD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00370275629047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00370275629047003702756290473702756290470370275629047

GMDN Terms#

Term, Definition table
TermDefinition
Artificial salivaAn electrolyte solution resembling human saliva designed in part to replace the normal ionic and pH balance of the oral cavity. The device is intended as a mouth rinse to moisten, lubricate, and clean the mucosa of the mouth, tongue, and throat. The device is indicated for dryness of the mouth or throat due to temporary or permanent conditions. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079212068
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00370275123088OralID Fitted GlassesOralID Fitted Glasses 1ct2025-01-22
00370275123705OralID Over GlassesOralID Over Glasses 1ct2025-01-22
00370275092025FS Dispenser, StainlessStainless FS Dispenser 1ct2024-10-14
00370275091011FS DispenserFS Dispenser 1ct2024-02-21
00370275713050OrapeuticOrapeutic 5ct2024-02-14
00037027571305OrapeuticOrapeutic 5ct2024-02-14
00370275090168PerioStomPerioStom 16ct2024-02-14
00370275850106BioStomBioStom 1ct2024-02-14
00370275850250BioStomBioStom 25ct2024-02-14
00370275850502BioStomBioStom 10ct2024-02-14
00370275123163OralIDFS-112016-10-03
00370275629030SalivaMAXSalivaMAX 30ct2016-10-03
00370275629122SalivaMAXSalivaMAX 120Ct2016-10-03
00370275629306SalivaMAXSalivaMAX 300Ct2016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809334440016MucoPEG™SunBio, Inc.LFD2026-06-01
00350930098029Parnell Pharmaceuticals, Inc.Parnell Pharmaceuticals, Inc.LFD2026-05-21
00350930098081Parnell Pharmaceuticals, Inc.Parnell Pharmaceuticals, Inc.LFD2026-05-21
00858290006987Allday Oral Moisturizing Rinse, 10oz BottleELEVATE ORAL CARE, LLCLFD2026-05-01
00810051089004GuruNandaGurunanda, LLCLFD2026-01-28
00810051089479GuruNandaGurunanda, LLCLFD2026-01-28
00647692000132CloSYS Dry Mouth Sensitive Mouth RinseRowpar Pharmaceuticals, Inc.LFD2025-12-16
00899655002220SaliveaLACLEDE, INC.LFD2025-06-16
00697366003556SmartMouthTriumph Pharmaceuticals Inc.LFD2025-06-10
00697366003570SmartMouthTriumph Pharmaceuticals Inc.LFD2025-06-10
00850058655086Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
00850058655055Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
00850058655109Periovance Dry Mouth GelORABIO, INC.LFD2025-04-09
05060146293129Caphosol® Artifical SalivaEUSA PHARMA (UK) LIMITEDLFD2024-06-26
08426181972769Xerostom® Saliva Substitute GelBIO COSMETICS SLLFD2024-04-01
05060146291576CaphosolEUSA PHARMA (UK) LIMITEDLFD2024-03-27
00304369600421Moi-stir 4 oz w/ sprayerCentury Pharmaceuticals IncLFD2024-02-14
D132DMS0020CVS Dry Mouth SprayOralabs, LLCLFD2024-01-29
D132DMS0030MeijerOralabs, LLCLFD2024-01-29
00050428446102CVS Dry Mouth SprayOralabs, LLCLFD2024-01-29
00708820384446MeijerOralabs, LLCLFD2024-01-29
00858290006895Povi-OneELEVATE ORAL CARE, LLCLFD2023-09-27
00899655002213SaliveaLACLEDE, INC.LFD2023-09-22
00899655002251Salivea LACLEDE, INC.LFD2023-09-12
00899655002275SaliveaLACLEDE, INC.LFD2023-09-12
D132DMS0010CVS Dry Mouth SprayOralabs, LLCLFD2023-08-14
00858290006871Allday Spray/Gel Sample BagELEVATE ORAL CARE, LLCLFD2023-05-18
00048582001558BioteneHaleon US Holdings LLCLFD2023-04-14
00048582003309BioteneHaleon US Holdings LLCLFD2023-04-14
00048582004566BioteneHaleon US Holdings LLCLFD2023-04-14