Cleared Special

K013682 - MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM

K013682 is an FDA 510(k) clearance for MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM, manufactured by Basic Dental Implant Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 21-day FDA review.

K013682 · Basic Dental Implant Systems, Inc. · Dental device
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Nov 2001
Decision
21d
Days
Class 2
Risk

K013682 is an FDA 510(k) clearance for the MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Basic Dental Implant Systems, Inc. (Albuquerque, US). The FDA issued a Cleared decision on November 28, 2001 after a review of 21 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 Basic Dental Implant Systems, Inc. devices

FDA 510(k) Submission Details - K013682

510(k) Number K013682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date November 28, 2001
Days to Decision 21 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
106d faster than avg
Panel avg: 127d · This submission: 21d
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 937
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K013682.
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