Cleared Special

K072878 - MODIFICATION TO: LOCATOR IMPLANT ANCHOR

K072878 is an FDA 510(k) clearance for MODIFICATION TO: LOCATOR IMPLANT ANCHOR, 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 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.

FDA 510(k) Submission Details - K072878

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 128d · This submission: 55d
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 K072878.
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BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS
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SPI ART ABUTMENT
K073141 · Thommen Medical AG · Dec 2007
IMPLANTIUM PROSTHETICS
K070228 · Dentium Co., Ltd. · Nov 2007
ATLANTIS ABUTMENT IN ZIRCONIA FOR 3I CERTAIN MICROAMINI IMPLANTS, GEMINI ABUTMENT IN ZIRCONIA FOR ASTRA IMPLANTS
K072483 · Atlantis Components, Inc. · Nov 2007
PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS
K073032 · Lifecore Biomedical, Inc. · Nov 2007
K072878 · MODIFICATION TO: LOCATOR IMPLANT ANCHOR
Download PDF Zest Anchors, Inc.