Cleared Traditional

K183304 - Prettau

K183304 is an FDA 510(k) clearance for Prettau, manufactured by Zirkonzahn Srl. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K183304 · Zirkonzahn Srl · Dental device
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Apr 2019
Decision
127d
Days
Class 2
Risk

K183304 is an FDA 510(k) clearance for the Prettau, ICE, Z-White zirconia blanks. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Zirkonzahn Srl (Gais, IT). The FDA issued a Cleared decision on April 4, 2019 after a review of 127 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 Zirkonzahn Srl devices

FDA 510(k) Submission Details - K183304

510(k) Number K183304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2018
Decision Date April 04, 2019
Days to Decision 127 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
At panel average
Panel avg: 127d · This submission: 127d
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 285
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K183304.
KATANA Zirconia Block
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ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
K182833 · The Argen Corporation · Feb 2019