Cleared Special

K022912 - POST AND CORE - THIN FOR THE BASIC DENTAL IMPLANT SYSTEM

K022912 is an FDA 510(k) clearance for POST AND CORE - THIN FOR THE BASIC DENT..., 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 17-day FDA review.

K022912 · Basic Dental Implant Systems, Inc. · Dental device
Download Printable Device Report (PDF)
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Sep 2002
Decision
17d
Days
Class 2
Risk

K022912 is an FDA 510(k) clearance for the POST AND CORE - THIN FOR THE 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 September 20, 2002 after a review of 17 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 - K022912

510(k) Number K022912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date September 20, 2002
Days to Decision 17 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
110d faster than avg
Panel avg: 127d · This submission: 17d
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 K022912.
OCO DENTAL IMPLANT (5.0MM DIAMETER)
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REPLACE TIUNITE ENDOSSEOUS IMPLANT
K023113 · Nobel Biocare Uas, Inc. · Sep 2002
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K022113 · Implant Innovations, Inc. · Sep 2002
ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K022859 · Straumann USA · Sep 2002
VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
K012473 · Vident · Sep 2002