Cleared Traditional

K190518 - Color Liquid

K190518 is an FDA 510(k) clearance for Color Liquid, 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 263-day FDA review.

K190518 · Zirkonzahn Srl · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2019
Decision
263d
Days
Class 2
Risk

K190518 is an FDA 510(k) clearance for the Color Liquid, Vita Liquid. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Zirkonzahn Srl (Gais, IT). The FDA issued a Cleared decision on November 22, 2019 after a review of 263 days - an extended review 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: 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 - K190518

510(k) Number K190518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date November 22, 2019
Days to Decision 263 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
136d slower than avg
Panel avg: 127d · This submission: 263d
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 K190518.
Noritake Super Porcelain EX-3
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K190112 · Fine Advanced Compound Co., Ltd. · Dec 2019
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K191304 · Besorah Dental Solutions NZ Limited · Nov 2019
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K191631 · Zmaxx Bioceramics, LLC · Nov 2019