Cleared Traditional

K141659 - PRISM ZIRCONIA, ST-98

K141659 is an FDA 510(k) clearance for PRISM ZIRCONIA, manufactured by A & D Dental Innovations. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K141659 · A & D Dental Innovations · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
111d
Days
Class 2
Risk

K141659 is an FDA 510(k) clearance for the PRISM ZIRCONIA, ST-98. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by A & D Dental Innovations (Austin, US). The FDA issued a Cleared decision on October 9, 2014 after a review of 111 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.

FDA 510(k) Submission Details - K141659

510(k) Number K141659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2014
Decision Date October 09, 2014
Days to Decision 111 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
17d faster than avg
Panel avg: 128d · This submission: 111d
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 472
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K141659.
UPCERA COLORING LIQUID (I AND II )
K141723 · Liaoning Upcera Co., Ltd. · Oct 2014
UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK
K141724 · Liaoning Upcera Co., Ltd. · Oct 2014
Vericore Zirconia Blanks
K142670 · Whip Mix Corporation · Oct 2014
VERICORE ZIRCONIA BLANKS
K140877 · Whip-Mix Corp. · Sep 2014
ALL-CERAMIC ZIRCONIA BLOCK
K141162 · Rizhao Huge Dental Industry Co., Ltd. · Aug 2014
OBSIDIAN MILLING BLOCKS
K141788 · Prismatik Dentalcraft, Inc. · Aug 2014