Cleared Traditional

K874106 - GLANDOSANE (SALIVART) SYNTHETIC SALIVA (FDA 510(k) Clearance)

K874106 · Fresenius USA, Inc. · Dental device
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Apr 1988
Decision
189d
Days
-
Risk

K874106 is an FDA 510(k) clearance for the GLANDOSANE (SALIVART) SYNTHETIC SALIVA. Classified as Saliva, Artificial (product code LFD).

Submitted by Fresenius USA, Inc. (Germany, DE). The FDA issued a Cleared decision on April 15, 1988 after a review of 189 days - an extended review cycle.

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 Fresenius USA, Inc. devices

Submission Details

510(k) Number K874106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1987
Decision Date April 15, 1988
Days to Decision 189 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 127d · This submission: 189d
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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