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510(k) Data Aggregation
K Number
K051409Device Name
SLIVASURE
Manufacturer
SCANDINAVIAN FORMULAS, INC.
Date Cleared
2005-08-08
(69 days)
Product Code
LED
Regulation Number
864.1850Why did this record match?
Product Code :
LED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SalivaSure™ promotes lubrication of oral mucosa that may be dry due to the side effects of medication, chemo or radiotherapy, or as a symptom of Sjogren's Synolome, or because of orar real inflammation. SalivaSure™ provides temporary relief from dry mouth caused by reduced or damaged salivary function.
The Over The Counter labeling indicates that SalivaSure™ is suitable for relief from dry mouth.
Device Description
Not Found
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K Number
K023046Device Name
SST SALIVA SUPPORTING TABLETS
Manufacturer
SINCLAIR PHARMACEUTICALS, LTD.
Date Cleared
2002-12-02
(81 days)
Product Code
LED
Regulation Number
864.1850Why did this record match?
Product Code :
LED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, SINCLAIR SST™ promotes lubrication of oral mucosa that may be dry (xerostomia) due to, as may occur in a variety of circumstances including, medication, chemo or radiotherapy, Sjogren's Syndrome or oral inflammation. SINCLAIR SST TM provides temporary relief for damaged salivary function.
Over the counter labeling stipulates that SINCLAIR SST™ is suitable for temporary relief of dry mouth symptoms.
Device Description
SST™ is formulated as a tablet that is allowed to dissolve slowly in the mouth. The tablets are presented in containers of various counts. They contain a mixture of electrolytes in a pleasant flavored tablet.
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