Cleared Traditional

K182118 - armor LC (FDA 510(k) Clearance)

Class I Dental device.

K182118 · Mavrik Dental Systems, Ltd. · Dental device
May 2019
Decision
270d
Days
Class 1
Risk

K182118 is an FDA 510(k) clearance for the armor LC. Classified as Dam, Rubber (product code EIE), Class I - General Controls.

Submitted by Mavrik Dental Systems, Ltd. (Raanana, IL). The FDA issued a Cleared decision on May 3, 2019 after a review of 270 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6300 - 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.

Submission Details

510(k) Number K182118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2018
Decision Date May 03, 2019
Days to Decision 270 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 158d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIE Dam, Rubber
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6300
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.