Cleared Special

K072878 - MODIFICATION TO: LOCATOR IMPLANT ANCHOR

K072878 is the FDA 510(k) clearance for MODIFICATION TO: LOCATOR IMPLANT ANCHOR by Zest Anchors, Inc.. It is a Class 2 Dental device (product code NHA) cleared through the Special 510(k) pathway after a 55-day FDA review.

K072878 · Zest Anchors, Inc. · Dental device
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Dec 2007
Decision
55d
Days
Class 2
Risk

K072878 is an FDA 510(k) clearance for the MODIFICATION TO: LOCATOR IMPLANT ANCHOR. 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 December 3, 2007 after a review of 55 days - a notably fast clearance cycle.

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. 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 Zest Anchors, Inc. devices

Submission Details

510(k) Number K072878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2007
Decision Date December 03, 2007
Days to Decision 55 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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

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