Cleared Traditional

K142233 - zenostar MO

K142233 is the FDA 510(k) clearance for zenostar MO by Wieland Dental + Technik GmbH & Co. KG. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K142233 · Wieland Dental + Technik GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
145d
Days
Class 2
Risk

K142233 is an FDA 510(k) clearance for the zenostar MO, Zenostar T, Zenostar VisualiZr. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on January 5, 2015 after a review of 145 days - within the typical 510(k) review window.

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: 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 Wieland Dental + Technik GmbH & Co. KG devices

Submission Details

510(k) Number K142233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2014
Decision Date January 05, 2015
Days to Decision 145 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
18d slower than avg
Panel avg: 127d · This submission: 145d
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

Ivoclar Vivadent, Inc.
Donna Marie Hartnett

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 223
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K142233.
MSCB-001
K152274 · GC America, Inc. · Mar 2016
Zenostar MT, Zenostar Color Liquids
K152118 · Wieland Dental + Technik GmbH & Co. KG · Dec 2015
BruxZir Anterior Milling Blanks
K150872 · Prismatik Dentalcraft, Inc. · Jul 2015
BruxZir Anterior
K143330 · Prismatik Dentalcraft, Inc. · Dec 2014
OBSIDIAN PRESS (ALL CERAMIC AND POM)
K141887 · Prismatik Dentalcraft, Inc. · Nov 2014
OBSIDIAN MILLING BLOCKS
K141788 · Prismatik Dentalcraft, Inc. · Aug 2014