Cleared Traditional

K191631 - ZMAXX Dental Zirconia Blanks

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

K191631 · Zmaxx Bioceramics, LLC · Dental device
Download Printable Device Report (PDF)
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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

FDA 510(k) Submission Details - K191631

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.

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 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 401
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