Cleared Special

K083324 - LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM

K083324 is an FDA 510(k) clearance for LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM, manufactured by Zest Anchors, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 105-day FDA review.

K083324 · Zest Anchors, Inc. · Dental device
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Feb 2009
Decision
105d
Days
Class 2
Risk

K083324 is an FDA 510(k) clearance for the LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Zest Anchors, Inc. (Escondido, US). The FDA issued a Cleared decision on February 25, 2009 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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. Standard predicate reliance. 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 - K083324

510(k) Number K083324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2008
Decision Date February 25, 2009
Days to Decision 105 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 128d · This submission: 105d
Pathway characteristics
Modification to existing cleared device.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K083324.
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K083324 · LOCATOR IMPLANT ANCHOR ATTACHMENT SYSTEM
Download PDF Zest Anchors, Inc.