Cleared Traditional

K163476 - Lubricity

K163476 · You First Services, Incorporated · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K163476

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 128d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 45
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