Cleared Traditional

ORAL BALANCE LIQUID/ GEL

K061331 · Laclede, Inc. · Dental
Jul 2006
Decision
74d
Days
Risk

About This 510(k) Submission

K061331 is an FDA 510(k) clearance for the ORAL BALANCE LIQUID/ GEL, a Saliva, Artificial, submitted by Laclede, Inc. (Rancho Dominguez, US). The FDA issued a Cleared decision on July 25, 2006, 74 days after receiving the submission on May 12, 2006. This device falls under the Dental review panel.

Submission Details

510(k) Number K061331 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LFD — Saliva, Artificial
Device Class

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