Cleared Abbreviated

K142407 - Straight Stud Attachment

K142407 is an FDA 510(k) clearance for Straight Stud Attachment, manufactured by Sterngold Dental, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 118-day FDA review.

K142407 · Sterngold Dental, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
118d
Days
Class 2
Risk

K142407 is an FDA 510(k) clearance for the Straight Stud Attachment. 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 Sterngold Dental, LLC (Attleboro, US). The FDA issued a Cleared decision on December 24, 2014 after a review of 118 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sterngold Dental, LLC devices

FDA 510(k) Submission Details - K142407

510(k) Number K142407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2014
Decision Date December 24, 2014
Days to Decision 118 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 127d · This submission: 118d
Pathway characteristics
Standards-based clearance path.

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 542
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K142407.
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