Cleared Traditional

K142657 - XEROSTOM SALIVA SUBSTITUTE GEL

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.

FDA 510(k) Submission Details - K142657

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 128d · This submission: 361d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Consultant

Liberty Management Group , Ltd.
MANOJ ZACHARIAS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LFD Saliva, Artificial

All 45
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ORAMOIST
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