Search Results
Found 1 results
510(k) Data Aggregation
K Number
K152201Device Name
MedActive Oral Gel and Spray
Manufacturer
MedActive Oral Pharmaceuticals, LLC.
Date Cleared
2015-12-30
(146 days)
Product Code
LFD
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MedActive Oral Pharmaceuticals, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. Provides symptom relief from Dry Mouth and low saliva including:
- Oral discomfort
- Mucosal soft tissue dryness
- Oral side effects of illness, therapies, and medications
2. Soothes moistens and lubricates
3. Hydrates soft tissue
Device Description
MedActive Oral Gel and Spray are liquid delivery systems for ingredients that coat the inside of the mouth for a period of time and create relief from dry mouth symptoms in those who suffer oral malodor, discomfort, difficulties eating or speaking from dry mouth complications. They are applied by either a spray or gel to the user's mouth. MedActive Oral Gel and Spray are nonsterile ready to use devices to be used as needed or directed by a health care professional.
Ask a Question
Page 1 of 1