Cleared Special

K093642 - NEUTRASAL

K093642 · Invado Pharmaceuticals · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
17d
Days
-
Risk

K093642 is an FDA 510(k) clearance for the NEUTRASAL. Classified as Saliva, Artificial (product code LFD).

Submitted by Invado Pharmaceuticals (Pomona, US). The FDA issued a Cleared decision on December 11, 2009 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K093642

510(k) Number K093642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2009
Decision Date December 11, 2009
Days to Decision 17 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 128d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 45
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