Cleared Traditional

K073486 - DENTIS DENTAL IMPLANT SYSTEM

K073486 is the FDA 510(k) clearance for DENTIS DENTAL IMPLANT SYSTEM by Dentis Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K073486 · Dentis Co., Ltd. · Dental device
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Apr 2008
Decision
114d
Days
Class 2
Risk

K073486 is an FDA 510(k) clearance for the DENTIS DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentis Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on April 4, 2008 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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.

View all Dentis Co., Ltd. devices

Submission Details

510(k) Number K073486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2007
Decision Date April 04, 2008
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K073486.
HG II FIXTURE SYSTEM
K080744 · Osstem Implant Co., Ltd. · Jul 2008
NT/IT SYSTEM
K081078 · Osstem Implant Co., Ltd. · Jul 2008
US/GS ULTRA WIDE SYSTEM
K073465 · Osstem Implant Co., Ltd. · Apr 2008
FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
K073075 · Dentsply International, Inc. · Mar 2008
JNE IMPLANT SYSTEM
K072425 · GC America, Inc. · Mar 2008
US/SS/GS SYSTEM
K073247 · Osstem Implant Co., Ltd. · Mar 2008