Cleared Traditional

MD-FLEX HEAVY BODY (K134008) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K134008 · Meta Biomed, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
100d
Days
Class 2
Risk

K134008 is an FDA 510(k) clearance for the MD-FLEX HEAVY BODY. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Meta Biomed, Inc. (Mt. Airy, US). The FDA issued a Cleared decision on April 9, 2014 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Meta Biomed, Inc. devices

Submission Details

510(k) Number K134008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2013
Decision Date April 09, 2014
Days to Decision 100 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
27d faster than avg
Panel avg: 127d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 52
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K134008.
AIM2
K181011 · GC America, Inc. · Jul 2018
PEAK NS033CF, PEAK NS017CF
K180565 · Neosil Co., Ltd. · Jun 2018
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
K171562 · Dreve Dentamid GmbH · Apr 2018
PRE-IMPRESSION CONDITIONING SOLUTION
K061427 · Dentsply Intl. · Jun 2006
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
K021416 · Dentsply Intl. · May 2002
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
K021413 · Dentsply Intl. · May 2002