Cleared Traditional

K173971 - K2 Zirkon Blank white classic

Also marketed or referenced as:
K2 Zirkon Blank translucent K2 Blanks extreme translucent

K173971 is an FDA 510(k) clearance for K2 Zirkon Blank white classic, manufactured by Yeti Dentalprodukte GmbH. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K173971 · Yeti Dentalprodukte GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Yeti Dentalprodukte GmbH devices

FDA 510(k) Submission Details - K173971

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 127d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

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 401
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