Cleared Traditional

K173971 - K2 Zirkon Blank white classic (FDA 510(k) Clearance)

Also includes:
K2 Zirkon Blank translucent K2 Blanks extreme translucent

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

K173971 · Yeti Dentalprodukte GmbH · Dental device
Nov 2018
Decision
321d
Days
Class 2
Risk

K173971 is an FDA 510(k) clearance for the K2 Zirkon Blank white classic. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Yeti Dentalprodukte GmbH (Engen, DE). The FDA issued a Cleared decision on November 15, 2018 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K173971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2017
Decision Date November 15, 2018
Days to Decision 321 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 158d · This submission: 321d
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 Peers - EIH Powder, Porcelain

All 31
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