Cleared Traditional

K152201 - MedActive Oral Gel and Spray (FDA 510(k) Clearance)

K152201 · Medactive Oral Pharmaceuticals, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
146d
Days
-
Risk

K152201 is an FDA 510(k) clearance for the MedActive Oral Gel and Spray. Classified as Saliva, Artificial (product code LFD).

Submitted by Medactive Oral Pharmaceuticals, LLC (Odessa, US). The FDA issued a Cleared decision on December 30, 2015 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Dental 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Medactive Oral Pharmaceuticals, LLC devices

Submission Details

510(k) Number K152201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2015
Decision Date December 30, 2015
Days to Decision 146 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 127d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
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