Cleared Traditional

K152406 - SalivaMAX

K152406 · Forward Science, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
120d
Days
-
Risk

K152406 is an FDA 510(k) clearance for the SalivaMAX. Classified as Saliva, Artificial (product code LFD).

Submitted by Forward Science, LLC (Stafford, US). The FDA issued a Cleared decision on December 23, 2015 after a review of 120 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 Forward Science, LLC devices

FDA 510(k) Submission Details - K152406

510(k) Number K152406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2015
Decision Date December 23, 2015
Days to Decision 120 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
8d faster than avg
Panel avg: 128d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

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