Cleared Traditional

K191304 - EthanZir Zirconia

K191304 is the FDA 510(k) clearance for EthanZir Zirconia by Besorah Dental Solutions NZ Limited. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K191304 · Besorah Dental Solutions NZ Limited · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
174d
Days
Class 2
Risk

K191304 is an FDA 510(k) clearance for the EthanZir Zirconia. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Besorah Dental Solutions NZ Limited (Auckland, NZ). The FDA issued a Cleared decision on November 4, 2019 after a review of 174 days - an extended review 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: 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 Besorah Dental Solutions NZ Limited devices

Submission Details

510(k) Number K191304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2019
Decision Date November 04, 2019
Days to Decision 174 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
47d slower than avg
Panel avg: 127d · This submission: 174d
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

Rac Corporation
Robin A. Carden

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 260
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K191304.
Non-Sterile Zirconia Block
K190112 · Fine Advanced Compound Co., Ltd. · Dec 2019
Color Liquid, Vita Liquid
K190518 · Zirkonzahn Srl · Nov 2019
BruxZir GT (Gum Tissue) Color
K191903 · Prismatik Dentalcraft, Inc. · Nov 2019
ZMAXX Dental Zirconia Blanks
K191631 · Zmaxx Bioceramics, LLC · Nov 2019
Razor, Everest, U&C Liquid
K191902 · U&C International Co., Ltd. · Oct 2019
Vintage Art Universal
K191794 · Shofu Dental Corporation · Oct 2019