Cleared Traditional

ArgenZ MTZ (K242458) - FDA 510(k) Clearance

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

K242458 · Argen Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2024
Decision
66d
Days
Class 2
Risk

K242458 is an FDA 510(k) clearance for the ArgenZ MTZ. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Argen Corporation (San Diego, US). The FDA issued a Cleared decision on October 24, 2024 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Argen Corporation devices

Submission Details

510(k) Number K242458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2024
Decision Date October 24, 2024
Days to Decision 66 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
61d faster than avg
Panel avg: 127d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 Consultant

Trisler Consulting (Dba)
Patsy Trisler

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 - EIH Powder, Porcelain

All 184
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K242458.
Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
K242740 · Liaoning Rachcera Material Technology Co., Ltd. · Dec 2024
Estar-ZE
K242521 · Osstem Implant Co., Ltd. · Nov 2024
Dental Glass Ceramics Blocks (HT, LT, MT)
K242407 · Hunan Vsmile Biotechnology Co., Ltd. · Nov 2024
CEREC Cercon 4D CAD/CAM Blocks
K242462 · Dentsply Sirona · Oct 2024
Dental porcelain powder
K242400 · Yilink (Tianjin) Biotechnology Co., Ltd. · Oct 2024
LUXEN 5G
K241151 · Dentalmax Co., Ltd. · Sep 2024