Cleared Traditional

K062653 - MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098

K062653 · Parnell Pharmaceuticals, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
50d
Days
-
Risk

K062653 is an FDA 510(k) clearance for the MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098. Classified as Saliva, Artificial (product code LFD).

Submitted by Parnell Pharmaceuticals, Inc. (San Rafael, US). The FDA issued a Cleared decision on October 27, 2006 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K062653

510(k) Number K062653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2006
Decision Date October 27, 2006
Days to Decision 50 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
78d faster than avg
Panel avg: 128d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 48
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K062653.
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ORAL NEUTRALIZER
K071617 · Oral Biotech · Oct 2007
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K061331 · Laclede, Inc. · Jul 2006
TGO SPRAY
K051812 · Laboratoires Carilene S.A.S. · Oct 2005
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
K041563 · Glaxosmithkline Consumer Healthcare, L.P. · Aug 2004
K062653 · MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
Download PDF FDA Summary Parnell Pharmaceutica…