Cleared Traditional

K171167 - Prodigio Stain Powder

K171167 is an FDA 510(k) clearance for Prodigio Stain Powder, manufactured by Operart, LLC. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K171167 · Operart, LLC · Dental device
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Dec 2017
Decision
236d
Days
Class 2
Risk

K171167 is an FDA 510(k) clearance for the Prodigio Stain Powder. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Operart, LLC (Santa Monica, US). The FDA issued a Cleared decision on December 13, 2017 after a review of 236 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 Operart, LLC devices

FDA 510(k) Submission Details - K171167

510(k) Number K171167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2017
Decision Date December 13, 2017
Days to Decision 236 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d slower than avg
Panel avg: 127d · This submission: 236d
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 288
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K171167.
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CERABIEN ZR
K170834 · Kuraray Noritake Dental, Inc. · Oct 2017
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K170986 · Kuraray Noritake Dental, Inc. · Jul 2017