Cleared Traditional

K120552 - AIR LIFT/XEROSTOM ARTIFICIAL SALIVA

K120552 · Biocosmetics Laboratories · Dental device
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Jun 2012
Decision
104d
Days
-
Risk

K120552 is an FDA 510(k) clearance for the AIR LIFT/XEROSTOM ARTIFICIAL SALIVA. Classified as Saliva, Artificial (product code LFD).

Submitted by Biocosmetics Laboratories (Monroe, US). The FDA issued a Cleared decision on June 6, 2012 after a review of 104 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 - K120552

510(k) Number K120552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2012
Decision Date June 06, 2012
Days to Decision 104 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 128d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

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K120552 · AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
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