Cleared Traditional

K142657 - XEROSTOM SALIVA SUBSTITUTE GEL (FDA 510(k) Clearance)

K142657 · Bio Cosmetics, S.L. · Dental device
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Sep 2015
Decision
361d
Days
-
Risk

K142657 is an FDA 510(k) clearance for the XEROSTOM SALIVA SUBSTITUTE GEL. Classified as Saliva, Artificial (product code LFD).

Submitted by Bio Cosmetics, S.L. (Madrid, ES). The FDA issued a Cleared decision on September 14, 2015 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cosmetics, S.L. devices

Submission Details

510(k) Number K142657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2014
Decision Date September 14, 2015
Days to Decision 361 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
234d slower than avg
Panel avg: 127d · This submission: 361d
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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