Cleared Traditional

K091419 - VICKS POWERSHOT DRY THROAT & MOUTH RELIEF

K091419 · The Procter & Gamble Co. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
107d
Days
-
Risk

K091419 is an FDA 510(k) clearance for the VICKS POWERSHOT DRY THROAT & MOUTH RELIEF. Classified as Saliva, Artificial (product code LFD).

Submitted by The Procter & Gamble Co. (Mason, US). The FDA issued a Cleared decision on August 28, 2009 after a review of 107 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 - K091419

510(k) Number K091419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2009
Decision Date August 28, 2009
Days to Decision 107 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 faster than avg
Panel avg: 128d · This submission: 107d
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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K091419 · VICKS POWERSHOT DRY THROAT & MOUTH RELIEF
Download PDF FDA Summary The Procter & Gamble …