K130959 - AFTAMED MOUTHWASH (FDA 510(k) Clearance)

K130959 is an FDA 510(k) clearance for the AFTAMED MOUTHWASH. Classified as Oral Wound Dressing (product code OLR).

Submitted by Bioplax Limited (Bellingham, US). The FDA issued a Cleared decision on April 4, 2014 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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