Cleared Traditional

K130604 - UNIVERSAL PASTE STAINS AND GLAZE

K130604 is an FDA 510(k) clearance for UNIVERSAL PASTE STAINS AND GLAZE, manufactured by Prismatik Dentalcraft, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K130604 · Prismatik Dentalcraft, Inc. · Dental device
Download Printable Device Report (PDF)
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Sep 2013
Decision
189d
Days
Class 2
Risk

K130604 is an FDA 510(k) clearance for the UNIVERSAL PASTE STAINS AND GLAZE. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on September 12, 2013 after a review of 189 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 Prismatik Dentalcraft, Inc. devices

FDA 510(k) Submission Details - K130604

510(k) Number K130604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2013
Decision Date September 12, 2013
Days to Decision 189 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
62d slower than avg
Panel avg: 127d · This submission: 189d
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 330
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K130604.
OBSIDIAN MILLING BLOCKS
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ZENOLUX
K130184 · Wieland Dental + Technik GmbH & Co. KG · May 2013
VINTAGE MP PRESS OVER
K122614 · Shofu Dental Corporation · May 2013
BRUXZIR SHADED
K130924 · Prismatik Dentalcraft, Inc. · May 2013