Cleared Traditional

K120404 - MERZ DENTAL GMBH ARTEGRAL HD PREFORMED ...

K120404 is an FDA 510(k) clearance for MERZ DENTAL GMBH ARTEGRAL HD PREFORMED ..., manufactured by Merz Dental GmbH. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K120404 · Merz Dental GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
102d
Days
Class 2
Risk

K120404 is an FDA 510(k) clearance for the MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Merz Dental GmbH (Albuquerque, US). The FDA issued a Cleared decision on May 21, 2012 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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 Merz Dental GmbH devices

FDA 510(k) Submission Details - K120404

510(k) Number K120404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2012
Decision Date May 21, 2012
Days to Decision 102 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
25d faster than avg
Panel avg: 127d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELM Device Classification - Class 2, Special Controls

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
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 - ELM Denture, Plastic, Teeth

All 19
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K120404.
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984 · Ivoclar Vivadent, Inc. · Jan 2014
VERACIA
K121749 · Shofu Dental Corporation · Sep 2012
SR PHONARES II
K120736 · Ivoclar Vivadent, AG · May 2012
VERACIA SA
K113426 · Shofu Dental Corporation · Feb 2012
SR PHONARES NHC
K093331 · Ivoclar Vivadent, Inc. · Jan 2010
MONDIAL
K060994 · Heraeus Kulzer, Inc. · May 2006