Cleared Traditional

K140836 - ZIBONE ZIRCONIA BLOCKS

K140836 is an FDA 510(k) clearance for ZIBONE ZIRCONIA BLOCKS, manufactured by Coho Technology Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K140836 · Coho Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
441d
Days
Class 2
Risk

K140836 is an FDA 510(k) clearance for the ZIBONE ZIRCONIA BLOCKS. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Coho Technology Co., Ltd. (Taoyuan County, TW). The FDA issued a Cleared decision on June 17, 2015 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Coho Technology Co., Ltd. devices

FDA 510(k) Submission Details - K140836

510(k) Number K140836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2014
Decision Date June 17, 2015
Days to Decision 441 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
314d slower than avg
Panel avg: 127d · This submission: 441d
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 291
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K140836.
VINTAGE Art LF
K152451 · Shofu Dental Corporation · Dec 2015
IPS Ivocolor
K151894 · Ivoclar Vivadent, AG · Oct 2015
BruxZir Anterior Milling Blanks
K150872 · Prismatik Dentalcraft, Inc. · Jul 2015
KATANA Zirconia
K143439 · Kuraray Noritake Dental, Inc. · Feb 2015
zenostar MO, Zenostar T, Zenostar VisualiZr
K142233 · Wieland Dental + Technik GmbH & Co. KG · Jan 2015
BruxZir Anterior
K143330 · Prismatik Dentalcraft, Inc. · Dec 2014