Cleared Special

K010386 - DUO-DENT DENTAL IMPLANT

K010386 is an FDA 510(k) clearance for DUO-DENT DENTAL IMPLANT, manufactured by Duo-Dent Dental Implant Systems, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 19-day FDA review.

K010386 · Duo-Dent Dental Implant Systems, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
19d
Days
Class 2
Risk

K010386 is an FDA 510(k) clearance for the DUO-DENT DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Duo-Dent Dental Implant Systems, LLC (Grayslake, US). The FDA issued a Cleared decision on February 27, 2001 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Duo-Dent Dental Implant Systems, LLC devices

FDA 510(k) Submission Details - K010386

510(k) Number K010386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2001
Decision Date February 27, 2001
Days to Decision 19 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 127d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 1172
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K010386.
ITI DENTAL IMPLANT SYSTEM
K010291 · Straumann USA · May 2001
THE MAESTRO SYSTEM
K010458 · BioHorizons Implant Systems, Inc. · May 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · Institut Straumann AG · Mar 2001
ACE SDS 3.75MM SCREW DENTAL IMPLANT
K002075 · Ace Surgical Supply Co., Inc. · Feb 2001
OCO DENTAL IMPLANT
K010142 · "O" Co., Inc. · Feb 2001
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · Lifecore Biomedical, Inc. · Jan 2001