Cleared Traditional

K190569 - Shaders ZR

K190569 is the FDA 510(k) clearance for Shaders ZR by Digital Age Dental Lab. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K190569 · Digital Age Dental Lab · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
145d
Days
Class 2
Risk

K190569 is an FDA 510(k) clearance for the Shaders ZR. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Digital Age Dental Lab (Redondo Beach, US). The FDA issued a Cleared decision on July 29, 2019 after a review of 145 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 Digital Age Dental Lab devices

Submission Details

510(k) Number K190569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2019
Decision Date July 29, 2019
Days to Decision 145 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
18d slower than avg
Panel avg: 127d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - EIH Powder, Porcelain

All 260
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K190569.
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