Cleared Traditional

K091718 - NEUTRASAL

K091718 · Bartor Pharmacal Co., Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
83d
Days
-
Risk

K091718 is an FDA 510(k) clearance for the NEUTRASAL. Classified as Saliva, Artificial (product code LFD).

Submitted by Bartor Pharmacal Co., Inc. (Pomona, US). The FDA issued a Cleared decision on September 2, 2009 after a review of 83 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 - K091718

510(k) Number K091718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date September 02, 2009
Days to Decision 83 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
45d faster than avg
Panel avg: 128d · This submission: 83d
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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K091718 · NEUTRASAL
Download PDF FDA Summary Bartor Pharmacal Co.,…