Cleared Traditional

K120404 - MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH

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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 128d · 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 45
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K120404.
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