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510(k) Data Aggregation
K Number
K213114Device Name
BentrioTM Allergy Blocker
Manufacturer
Altamira Therapeutics, Inc.
Date Cleared
2022-06-24
(270 days)
Product Code
NUP
Regulation Number
880.5045Why did this record match?
Applicant Name (Manufacturer) :
Altamira Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bentrio™ is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, animal hair and dust mites.
Application of Bentrio™ produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance.
Device Description
Bentrio™ is a gel emulsion which is applied as a nasal spray for self-protection. It is intended to help protect against allergens such as pollen, house dust, animal hair and dust mites, which are inhaled through your nose and may cause allergic reactions. Bentrio™ is free of any medication such as antihistamines or steroids and does not contain any preservatives.
The gel formulation of Bentrio™ has been designed for extended residence time within the nose. Upon shaking of the spray bottle, it turns liquid which allows for spraying into the nose. After contact with the nasal mucosa, the formulation returns to its gel state and creates the protective barrier. Bentrio™ is cleared from the nasal cavities over time into the throat and eliminated via the digestive tract.
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