Cleared Traditional

K192535 - Unshaded Dental Zirconia and Pre-Shaded...

K192535 is the FDA 510(k) clearance for Unshaded Dental Zirconia and Pre-Shaded... by Qinhuangdao Audental Metal Technology Co., Ltd.. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K192535 · Qinhuangdao Audental Metal Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
137d
Days
Class 2
Risk

K192535 is an FDA 510(k) clearance for the Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Qinhuangdao Audental Metal Technology Co., Ltd. (Qinhuangdao, CN). The FDA issued a Cleared decision on January 31, 2020 after a review of 137 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 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 Qinhuangdao Audental Metal Technology Co., Ltd. devices

Submission Details

510(k) Number K192535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2019
Decision Date January 31, 2020
Days to Decision 137 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
10d slower than avg
Panel avg: 127d · This submission: 137d
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

Beijing Believe-Med Technology Service Co., Ltd.
Ray Wang

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 K192535.
VITA Ambria
K193436 · Vita Zahnfabrik GmbH H Rauter & CO · May 2020
Purzir Dental Zirconia
K193055 · 3DBiocad · May 2020
DD Contrast
K193588 · Dental Direkt GmbH · Apr 2020
Noritake Super Porcelain EX-3
K193060 · Kuraray Noritake Dental, Inc. · Jan 2020
Livento Press, Soprano 10, Soprano
K192251 · Cendres & Metaux SA · Jan 2020
Non-Sterile Zirconia Block
K190112 · Fine Advanced Compound Co., Ltd. · Dec 2019