Cleared Traditional

ORAL NEUTRALIZER (K071617) - FDA 510(k) Clearance

K071617 · Oral Biotech · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
128d
Days
-
Risk

K071617 is an FDA 510(k) clearance for the ORAL NEUTRALIZER. Classified as Saliva, Artificial (product code LFD).

Submitted by Oral Biotech (Albany, US). The FDA issued a Cleared decision on October 19, 2007 after a review of 128 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.

View all Oral Biotech devices

Submission Details

510(k) Number K071617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2007
Decision Date October 19, 2007
Days to Decision 128 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 127d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
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