Cleared Traditional

K182118 - armor LC

K182118 is an FDA 510(k) clearance for armor LC, manufactured by Mavrik Dental Systems, Ltd.. The device is a Class 1 Dental device with product code EIE cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K182118 · Mavrik Dental Systems, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K182118

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 128d · This submission: 270d
Pathway characteristics
Predicate-based equivalence.

EIE Device Classification - Class 1, General Controls

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.

Regulatory Consultant

Heyer Regulatory Solutions, LLC
Sherwyn Davidson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EIE Dam, Rubber

All 31
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K182118.
Triumph Resin Dam
K151945 · Denali Corporation · Feb 2016
BARI-KAD PACKING DEVICE
K050318 · Bioenvelop Agro, Inc. · Mar 2005
GC TION GINGIVAL PROTECTOR
K043301 · GC America, Inc. · Jan 2005
BRITESMILE MASKING CREAM
K040797 · Britesmile, Inc. · Apr 2004
PULPDENT PUTTY DAM
K022522 · Pulpdent Corporation · Sep 2002
LIGHT CURE DENTAL DAM
K021524 · Prime Dental Manufacturing, Inc. · Jul 2002
K182118 · armor LC
Download PDF FDA Summary Mavrik Dental Systems…