Cleared Traditional

K163476 - Lubricity (FDA 510(k) Clearance)

K163476 · You First Services, Incorporated · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
149d
Days
-
Risk

K163476 is an FDA 510(k) clearance for the Lubricity. Classified as Saliva, Artificial (product code LFD).

Submitted by You First Services, Incorporated (Amherst, US). The FDA issued a Cleared decision on May 10, 2017 after a review of 149 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 You First Services, Incorporated devices

Submission Details

510(k) Number K163476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date May 10, 2017
Days to Decision 149 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
22d slower than avg
Panel avg: 127d · This submission: 149d
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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