Cleared Traditional

K072306 - BIOXTRA MOISTURIZING GEL

K072306 · Bio-X Healthcare S.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
90d
Days
-
Risk

K072306 is an FDA 510(k) clearance for the BIOXTRA MOISTURIZING GEL. Classified as Saliva, Artificial (product code LFD).

Submitted by Bio-X Healthcare S.A. (Washington, US). The FDA issued a Cleared decision on November 15, 2007 after a review of 90 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 Bio-X Healthcare S.A. devices

FDA 510(k) Submission Details - K072306

510(k) Number K072306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2007
Decision Date November 15, 2007
Days to Decision 90 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
38d faster than avg
Panel avg: 128d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 45
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K072306.
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K071617 · Oral Biotech · Oct 2007
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K062653 · Parnell Pharmaceuticals, Inc. · Oct 2006
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K061331 · Laclede, Inc. · Jul 2006