Cleared Traditional

K193055 - Purzir Dental Zirconia

K193055 is the FDA 510(k) clearance for Purzir Dental Zirconia by 3DBiocad. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K193055 · 3DBiocad · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
194d
Days
Class 2
Risk

K193055 is an FDA 510(k) clearance for the Purzir Dental Zirconia. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by 3DBiocad (Renton, US). The FDA issued a Cleared decision on May 13, 2020 after a review of 194 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 3DBiocad devices

Submission Details

510(k) Number K193055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2019
Decision Date May 13, 2020
Days to Decision 194 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
67d slower than avg
Panel avg: 127d · This submission: 194d
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

Emergo Global Consulting, LLC
Stuart R. Goldman

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 K193055.
BruxZir Steel
K200131 · Prismatik Dentalcraft, Inc. · Jun 2020
Dental Zirconia Blocks
K192262 · De Corematrix Co., Ltd. · May 2020
VITA Ambria
K193436 · Vita Zahnfabrik GmbH H Rauter & CO · May 2020
DD Contrast
K193588 · Dental Direkt GmbH · Apr 2020
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
K192535 · Qinhuangdao Audental Metal Technology Co., Ltd. · Jan 2020
Noritake Super Porcelain EX-3
K193060 · Kuraray Noritake Dental, Inc. · Jan 2020