Cleared Traditional

K151789 - LOCATOR F-Tx Attachment System

K151789 is an FDA 510(k) clearance for LOCATOR F-Tx Attachment System, manufactured by Zest Anchors, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K151789 · Zest Anchors, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
247d
Days
Class 2
Risk

K151789 is an FDA 510(k) clearance for the LOCATOR F-Tx 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, LLC (Escondido, US). The FDA issued a Cleared decision on March 4, 2016 after a review of 247 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Zest Anchors, LLC devices

FDA 510(k) Submission Details - K151789

510(k) Number K151789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date March 04, 2016
Days to Decision 247 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 127d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 534
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K151789.
VARIOunite
K160244 · Thommen Medical AG · Jun 2016
Thommen Milling Abutment for CAD/CAM
K151984 · Thommen Medical AG · Mar 2016
Straumann RN Gold Abutment for Bridge
K151590 · Straumann USA, LLC · Mar 2016
ATLANTIS ISUS
K151439 · Dentsply International, Inc. · Feb 2016
ATLANTIS Abutment for NobelActive 3.0
K151039 · Dentsply International, Inc. · Jan 2016
BioHorizons CAD/CAM Abutments
K151621 · BioHorizons Implant Systems, Inc. · Jan 2016