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) Official FDA 510(k) Summary (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.

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
1053d slower than avg
Panel avg: 128d · 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 48
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K981693.
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
K041563 · Glaxosmithkline Consumer Healthcare, L.P. · Aug 2004
CAPHOSOL
K030802 · Inpharma A.S. · Nov 2003
SALINUM, ORCLAIR
K024148 · Sinclair Pharmaceuticals, Ltd. · Sep 2003
CAPHOSOL ARTIFICIAL SALIVA
K991938 · Inpharma A.S. · Aug 1999
GLANDOSANE (SALIVART) SYNTHETIC SALIVA
K874106 · Fresenius USA, Inc. · Apr 1988
THROAT MOI-STIR
K840807 · Kingswood Laboratories, Inc. · May 1984
K981693 · SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
Download PDF FDA Summary Gebauer Co.