Cleared Traditional

K152383 - Ceramill Zolid FX

K152383 is an FDA 510(k) clearance for Ceramill Zolid FX, manufactured by Emergo Europe Consulting. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K152383 · Emergo Europe Consulting · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
28d
Days
Class 2
Risk

K152383 is an FDA 510(k) clearance for the Ceramill Zolid FX. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Emergo Europe Consulting (The Hague, NL). The FDA issued a Cleared decision on September 21, 2015 after a review of 28 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K152383

510(k) Number K152383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2015
Decision Date September 21, 2015
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 128d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Tuv Sud America, Inc.
Olaf Teichert

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 471
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K152383.
Luminesse Anterior Zirconia AT
K152066 · Talladium, Inc. · Oct 2015
Rainbow Shade
K151844 · Genoss · Oct 2015
PRETTAU ANTERIOR T0
K151490 · Zirkonzahn GmbH · Oct 2015
ArgenZ Esthetic Plus
K150919 · The Argen Corporation · Jul 2015
StarCeram® Z-Nature, StarCeram® Z-Smile
K143656 · H.C. Starck Ceramics GmbH · Jul 2015
BruxZir Anterior Milling Blanks
K150872 · Prismatik Dentalcraft, Inc. · Jul 2015