Cleared Abbreviated

VITA YZ ST and VITA YZ XT (K180703) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K180703 · Vita Zahnfabrik H.Rauter GmbH & Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
135d
Days
Class 2
Risk

K180703 is an FDA 510(k) clearance for the VITA YZ ST and VITA YZ XT. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Vita Zahnfabrik H.Rauter GmbH & Co. (Bad Sackingen, DE). The FDA issued a Cleared decision on August 1, 2018 after a review of 135 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Vita Zahnfabrik H.Rauter GmbH & Co. devices

Submission Details

510(k) Number K180703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2018
Decision Date August 01, 2018
Days to Decision 135 days
Submission Type Abbreviated
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
8d slower than avg
Panel avg: 127d · This submission: 135d
Pathway characteristics
Standards-based clearance path.

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

Vita North America
Nevine Erian

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 K180703.
LUXEN Zr, LUXEN Smile
K171585 · Dentalmax Co., Ltd. · Oct 2018
Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
K181167 · Liaoning Upcera Co., Ltd. · Sep 2018
Z-CAD smile
K170050 · Metoxit AG · Aug 2018
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
K180252 · Crown Porcelain Dental Technology Co., Ltd. · Apr 2018
DMAX Coloring Liquid
K173769 · Dmax Co., Ltd. · Mar 2018
n!ce for Planmill
K173410 · Institut Straumann AG · Nov 2017