Cleared Traditional

K191631 - ZMAXX Dental Zirconia Blanks

K191631 is the FDA 510(k) clearance for ZMAXX Dental Zirconia Blanks by Zmaxx Bioceramics, LLC. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K191631 · Zmaxx Bioceramics, LLC · Dental device
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Nov 2019
Decision
135d
Days
Class 2
Risk

K191631 is an FDA 510(k) clearance for the ZMAXX Dental Zirconia Blanks. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Zmaxx Bioceramics, LLC (Foster, US). The FDA issued a Cleared decision on November 1, 2019 after a review of 135 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 Zmaxx Bioceramics, LLC devices

Submission Details

510(k) Number K191631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2019
Decision Date November 01, 2019
Days to Decision 135 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
8d slower than avg
Panel avg: 127d · This submission: 135d
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

Mid-Link Consulting Co, Ltd.
Ying Xu

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
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