Cleared Traditional

K262685 - Zirconia Collective 4Y Dental Zirconia Blank

K262685 is an FDA 510(k) clearance for Zirconia Collective 4Y Dental Zirconia ..., manufactured by Zirconia Collective, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K262685 · Zirconia Collective, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
91d
Days
Class 2
Risk

K262685 is an FDA 510(k) clearance for the Zirconia Collective 4Y Dental Zirconia Blank. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Zirconia Collective, Inc. (Westminster, US). The FDA issued a Cleared decision on October 30, 2026 after a review of 91 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.

FDA 510(k) Submission Details - K262685

510(k) Number K262685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2026
Decision Date October 30, 2026
Days to Decision 91 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
37d faster than avg
Panel avg: 128d · This submission: 91d
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 Peers - EIH Powder, Porcelain

All 487
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K262685.
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K262074 · Mediclus Co., Ltd. · Aug 2026
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K262239 · Prismatik Dentalcraft, Inc. · Jul 2026
Dental Zirconia Blank & Coloring Liquid
K261046 · Hunan Qinghao Puzhong Technology Co., Ltd. · Jul 2026
K262685 · Zirconia Collective 4Y Dental Zirconia Blank
Download PDF FDA Summary Zirconia Collective, …