Cleared Traditional

K061331 - ORAL BALANCE LIQUID/ GEL

K061331 · Laclede, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
74d
Days
-
Risk

K061331 is an FDA 510(k) clearance for the ORAL BALANCE LIQUID/ GEL. Classified as Saliva, Artificial (product code LFD).

Submitted by Laclede, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on July 25, 2006 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Laclede, Inc. devices

FDA 510(k) Submission Details - K061331

510(k) Number K061331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2006
Decision Date July 25, 2006
Days to Decision 74 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
54d faster than avg
Panel avg: 128d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 43
Devices cleared under the same product code (LFD) and FDA review panel - the closest regulatory comparables to K061331.
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TGO SPRAY
K051812 · Laboratoires Carilene S.A.S. · Oct 2005
OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
K041563 · Glaxosmithkline Consumer Healthcare, L.P. · Aug 2004
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
K981693 · Gebauer Co. · Aug 2001