Cleared Traditional

K180680 - Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray (FDA 510(k) Clearance)

K180680 · Laclede, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
210d
Days
-
Risk

K180680 is an FDA 510(k) clearance for the Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray. Classified as Saliva, Artificial (product code LFD).

Submitted by Laclede, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on October 11, 2018 after a review of 210 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 Laclede, Inc. devices

Submission Details

510(k) Number K180680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2018
Decision Date October 11, 2018
Days to Decision 210 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 127d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 49
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K180680.
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