Cleared Traditional

K051812 - TGO SPRAY

K051812 · Laboratoires Carilene S.A.S. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
108d
Days
-
Risk

K051812 is an FDA 510(k) clearance for the TGO SPRAY. Classified as Saliva, Artificial (product code LFD).

Submitted by Laboratoires Carilene S.A.S. (Washington, US). The FDA issued a Cleared decision on October 21, 2005 after a review of 108 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K051812

510(k) Number K051812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2005
Decision Date October 21, 2005
Days to Decision 108 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
20d faster than avg
Panel avg: 128d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 48
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K041563 · Glaxosmithkline Consumer Healthcare, L.P. · Aug 2004
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K051812 · TGO SPRAY
Download PDF FDA Summary Laboratoires Carilene…