Cleared Traditional

K131396 - WIRED MOUTH PROTECTOR (WMP) (FDA 510(k) Clearance)

Class I Dental device.

K131396 · Elba Laboratories, Inc. · Dental device
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Sep 2013
Decision
138d
Days
Class 1
Risk

K131396 is an FDA 510(k) clearance for the WIRED MOUTH PROTECTOR (WMP). Classified as Intraoral, Dental Foam Protector (product code PFL), Class I - General Controls.

Submitted by Elba Laboratories, Inc. (Ferndale, US). The FDA issued a Cleared decision on September 30, 2013 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6890 - the FDA dental device regulatory framework. 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 Elba Laboratories, Inc. devices

Submission Details

510(k) Number K131396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2013
Decision Date September 30, 2013
Days to Decision 138 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
11d slower than avg
Panel avg: 127d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PFL Intraoral, Dental Foam Protector
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6890
Definition Intended To Provide A Soft Barrier Between Wired Mouth Hardware And Oral Mucosa.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.