Cleared Abbreviated

K072425 - JNE IMPLANT SYSTEM

K072425 is the FDA 510(k) clearance for JNE IMPLANT SYSTEM by GC America, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Abbreviated 510(k) pathway after a 194-day FDA review.

K072425 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
194d
Days
Class 2
Risk

K072425 is an FDA 510(k) clearance for the JNE IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by GC America, Inc. (Lake Forest, US). The FDA issued a Cleared decision on March 10, 2008 after a review of 194 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 GC America, Inc. devices

Submission Details

510(k) Number K072425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2007
Decision Date March 10, 2008
Days to Decision 194 days
Submission Type Abbreviated
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
67d slower than avg
Panel avg: 127d · This submission: 194d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 581
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K072425.
US/GS ULTRA WIDE SYSTEM
K073465 · Osstem Implant Co., Ltd. · Apr 2008
DENTIS DENTAL IMPLANT SYSTEM
K073486 · Dentis Co., Ltd. · Apr 2008
FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
K073075 · Dentsply International, Inc. · Mar 2008
US/SS/GS SYSTEM
K073247 · Osstem Implant Co., Ltd. · Mar 2008
HU II / HS II FIXTURE SYSTEM
K080387 · Osstem Implant Co., Ltd. · Mar 2008
ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS
K073067 · Dentsply International, Inc. · Feb 2008