Cleared Traditional

K874106 - GLANDOSANE (SALIVART) SYNTHETIC SALIVA

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

FDA 510(k) Submission Details - K874106

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 127d · This submission: 189d
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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