Cleared Special

LOCATOR® Angled Abutment (K252944) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252944 · Zest Anchors, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
30d
Days
Class 2
Risk

K252944 is an FDA 510(k) clearance for the LOCATOR® Angled Abutment. 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 (Carlsbad, US). The FDA issued a Cleared decision on October 15, 2025 after a review of 30 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, LLC devices

Submission Details

510(k) Number K252944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2025
Decision Date October 15, 2025
Days to Decision 30 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
97d faster than avg
Panel avg: 127d · This submission: 30d
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

All 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K252944.
S.I.N. Dental Implant System
K252266 · S.I.N. Implant System Ltda · Oct 2025
Elos Accurate Hybrid Base
K251497 · Elos Medtech Pinol A/S · Oct 2025
Bonafix Implant Abutments
K251294 · Zentek Medical, LLC · Oct 2025
SFIT Abutment
K242287 · Cowellmedi Co., Ltd. · Sep 2025
Customized Abutment and Screw
K242768 · Chengdu Besmile Medical Technology Co., Ltd. · Sep 2025
LOCATOR® Angled Abutment
K250721 · Zest Anchors, LLC · Aug 2025