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)
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.

View all Mavrik Dental Systems, Ltd. devices

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
143d slower than avg
Panel avg: 127d · 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 11
Devices cleared under the same product code (EIE) and FDA review panel - the closest regulatory comparables to K182118.
GC TION GINGIVAL PROTECTOR
K043301 · GC America, Inc. · Jan 2005
PULPDENT PUTTY DAM
K022522 · Pulpdent Corporation · Sep 2002
NIVEOUS LIQUID DAM
K021613 · Shofu Dental Corp. · Jun 2002
POWER BLOCK
K983227 · Kreativ, Inc. · Dec 1998
FASTDAM
K972775 · Interdent, Inc. · Feb 1998
DENTAL DAM SILICONE
K961472 · Worldwide Dental, Inc. · Aug 1996