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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 128d · 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 1546
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K010386.
THE MAESTRO SYSTEM
K010458 · BioHorizons Implant Systems, Inc. · May 2001
SENOJ IMPLANT SYSTEM
K000889 · Senoj Biocare, Inc. · Apr 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · Institut Straumann AG · Mar 2001
BMR DENTAL IMPLANT SYSTEM, MODEL 3.3XX, EITHER HA OR TPS COATED, 3.308, 3.310,3.312, 3.314 3.316
K010343 · Buck Medical Research · Feb 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
K010386 · DUO-DENT DENTAL IMPLANT
Download PDF FDA Summary Duo-Dent Dental Impla…