Cleared Traditional

K152201 - MedActive Oral Gel and Spray

K152201 · Medactive Oral Pharmaceuticals, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K152201

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 128d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 45
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K152201.
Hydris™ Oral Rinse
K163029 · Biopharm Consult, LLC · Jun 2017
Lubricity
K163476 · You First Services, Incorporated · May 2017
Caphosol Artifical Saliva Tablets
K162167 · Eusa Pharma (Uk) Limited · Mar 2017
SalivaMAX
K152406 · Forward Science, LLC · Dec 2015
XEROSTOM SALIVA SUBSTITUTE GEL
K142657 · Bio Cosmetics, S.L. · Sep 2015
Elevate Moisturizing Spray
K150074 · Elevate Oral Care · Jun 2015