Cleared Abbreviated

zirkon (K251084) - FDA 510(k) Clearance

Also marketed or referenced as:
structure LFU shades, stains and glazes

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K251084 · Estetic Ceram AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
57d
Days
Class 2
Risk

K251084 is an FDA 510(k) clearance for the zirkon. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Estetic Ceram AG (Triesen, LI). The FDA issued a Cleared decision on June 5, 2025 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Estetic Ceram AG devices

Submission Details

510(k) Number K251084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2025
Decision Date June 05, 2025
Days to Decision 57 days
Submission Type Abbreviated
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
70d faster than avg
Panel avg: 127d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

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

Novineon Cro
Anna Pocsai

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 184
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