Cleared Traditional

K083543 - DENOVISMED DENTAL IMPLANT SYSTEMS

K083543 is an FDA 510(k) clearance for DENOVISMED DENTAL IMPLANT SYSTEMS, manufactured by Denovis Medical, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K083543 · Denovis Medical, LLC · Dental device
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Mar 2009
Decision
98d
Days
Class 2
Risk

K083543 is an FDA 510(k) clearance for the DENOVISMED DENTAL IMPLANT SYSTEMS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Denovis Medical, LLC (San Diego, US). The FDA issued a Cleared decision on March 6, 2009 after a review of 98 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 Denovis Medical, LLC devices

FDA 510(k) Submission Details - K083543

510(k) Number K083543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2008
Decision Date March 06, 2009
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 935
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K083543.
HS II SHORT FIXTURE SYSTEM
K083633 · Osstem Implant Co., Ltd. · May 2009
I-FIX SYSTEM
K083586 · Dentis Co., Ltd. · Apr 2009
HG II FIXTURE SYSTEM
K090237 · Hiossen, Inc. · Apr 2009
STRAUMANN DENTAL IMPLANT SYSTEM
K083550 · Straumann USA · Feb 2009
STRAUMANN DENTAL IMPLANT SYSTEM
K081419 · Institut Straumann AG · Feb 2009
NOBELACTIVE 8.5 MM & 18.0 MM
K083205 · Nobel Biocare AB · Feb 2009