Cleared Traditional

K981693 - SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25

K981693 · Gebauer Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
1181d
Days
-
Risk

K981693 is an FDA 510(k) clearance for the SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER.... Classified as Saliva, Artificial (product code LFD).

Submitted by Gebauer Co. (Cleveland, US). The FDA issued a Cleared decision on August 6, 2001 after a review of 1181 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Gebauer Co. devices

FDA 510(k) Submission Details - K981693

510(k) Number K981693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1998
Decision Date August 06, 2001
Days to Decision 1181 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1054d slower than avg
Panel avg: 127d · This submission: 1181d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 18
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K981693.
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K101346 · GC America, Inc. · Jan 2011
GLANDOSANE (SALIVART) SYNTHETIC SALIVA
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