Cleared Traditional

K071617 - ORAL NEUTRALIZER

K071617 · Oral Biotech · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K071617

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 128d · This submission: 128d
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 K071617.
NEUTRASAL
K091718 · Bartor Pharmacal Co., Inc. · Sep 2009
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K091419 · The Procter & Gamble Co. · Aug 2009
BIOXTRA MOISTURIZING GEL
K072306 · Bio-X Healthcare S.A. · Nov 2007
MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
K062653 · Parnell Pharmaceuticals, Inc. · Oct 2006
ORAL BALANCE LIQUID/ GEL
K061331 · Laclede, Inc. · Jul 2006
TGO SPRAY
K051812 · Laboratoires Carilene S.A.S. · Oct 2005
K071617 · ORAL NEUTRALIZER
Download PDF FDA Summary Oral Biotech