Cleared Abbreviated

K110719 - ORIGIN ZIRCONIA

K110719 is an FDA 510(k) clearance for ORIGIN ZIRCONIA, manufactured by B&D Dental Technologies. The device is a Class 2 Dental device with product code EIH cleared through the Abbreviated 510(k) pathway after a 149-day FDA review.

K110719 · B&D Dental Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
149d
Days
Class 2
Risk

K110719 is an FDA 510(k) clearance for the ORIGIN ZIRCONIA. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by B&D Dental Technologies (West Valley, US). The FDA issued a Cleared decision on August 11, 2011 after a review of 149 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all B&D Dental Technologies devices

FDA 510(k) Submission Details - K110719

510(k) Number K110719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2011
Decision Date August 11, 2011
Days to Decision 149 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
Pathway characteristics
Standards-based clearance path.

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 304
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K110719.
CERCON HT
K112152 · Dentsply International, Inc. · Nov 2011
ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR
K112710 · Wieland Dental + Technik GmbH & Co. KG · Oct 2011
THE INSYNC CERAMIC SYSTEM
K111743 · Jensen Industries, Inc. · Sep 2011
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
K103556 · Ivoclar Vivadent, Inc. · Apr 2011
ZENOFLEX DIMENSION
K103773 · Wieland Dental + Technik GmbH & Co. KG · Mar 2011
ZENOSTAR MAGIC GLAZE
K103494 · Wieland Dental + Technik GmbH & Co. KG · Feb 2011