Cleared Traditional

K122663 - ORAMOIST

K122663 · Quantum, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
272d
Days
-
Risk

K122663 is an FDA 510(k) clearance for the ORAMOIST. Classified as Saliva, Artificial (product code LFD).

Submitted by Quantum, Inc. (Solon, US). The FDA issued a Cleared decision on May 30, 2013 after a review of 272 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.

FDA 510(k) Submission Details - K122663

510(k) Number K122663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2012
Decision Date May 30, 2013
Days to Decision 272 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
144d slower than avg
Panel avg: 128d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

LFD Device Classification - Class 0,

Product Code LFD Saliva, Artificial
Device Class -

Regulatory Peers - LFD Saliva, Artificial

All 46
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K123731 · Glaxosmithkline Consumer Healthcare (Gskch) · Jan 2013
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K120552 · Biocosmetics Laboratories · Jun 2012
DRY MOUTH MOUTHWASH
K111250 · Dr. Fresh, Inc. · Apr 2012
K122663 · ORAMOIST
Download PDF FDA Summary Quantum, Inc.