Cleared Special

K012299 - MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM

K012299 is an FDA 510(k) clearance for MODIFICATION TO: STRAIGHT POST AND CORE..., 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 12-day FDA review.

K012299 · Basic Dental Implant Systems, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
12d
Days
Class 2
Risk

K012299 is an FDA 510(k) clearance for the MODIFICATION TO: STRAIGHT POST AND CORE II 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 August 1, 2001 after a review of 12 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 - K012299

510(k) Number K012299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2001
Decision Date August 01, 2001
Days to Decision 12 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
116d faster than avg
Panel avg: 128d · This submission: 12d
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 1499
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K012299.
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K991822 · Dr. Ihde Dental AG Switzerland · Aug 2001
HA-TI (HAND TITANIUM SCREW) IMPLANT
K003045 · Hati Dental Ag. · Jul 2001
TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS
K003818 · Titan Implants · Jul 2001
ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM
K011245 · Sulzer Dental, Inc. · Jun 2001
K012299 · MODIFICATION TO: STRAIGHT POST AND CORE II FOR THE BASIC DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Basic Dental Implant …