Cleared Abbreviated

K132585 - ZIBONE CERAMIC DENTAL IMPLANT SYSTEM

K132585 is an FDA 510(k) clearance for ZIBONE CERAMIC DENTAL IMPLANT SYSTEM, manufactured by Coho Technology Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 292-day FDA review.

K132585 · Coho Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2014
Decision
292d
Days
Class 2
Risk

K132585 is an FDA 510(k) clearance for the ZIBONE CERAMIC DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Coho Technology Co., Ltd. (Flagstaff, US). The FDA issued a Cleared decision on June 4, 2014 after a review of 292 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Coho Technology Co., Ltd. devices

FDA 510(k) Submission Details - K132585

510(k) Number K132585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2013
Decision Date June 04, 2014
Days to Decision 292 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 127d · This submission: 292d
Pathway characteristics
Standards-based clearance path.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 838
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K132585.
HIOSSEN IMPLANT SYSTEM
K140934 · Hiossen, Inc. · Nov 2014
ZIMMER 3.1MM DENTAL IMPLANT
K142082 · Zimmer Dental, Inc. · Oct 2014
STRAUMANN BONE LEVEL TAPERED IMPLANT
K140878 · Straumann USA, LLC · Aug 2014
NOBELACTIVE WIDE PLATFORM (WP)
K133731 · Nobel Biocare AB · May 2014
ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED
K133339 · Zimmer Dental, Inc. · Mar 2014
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
K132258 · Zimmer Dental, Inc. · Nov 2013