Cleared Abbreviated

K142667 - Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm

K142667 is an FDA 510(k) clearance for Stern AC 3.3x10mm, manufactured by Sterngold Dental, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 110-day FDA review.

K142667 · Sterngold Dental, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
110d
Days
Class 2
Risk

K142667 is an FDA 510(k) clearance for the Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sterngold Dental, LLC (Attleboro, US). The FDA issued a Cleared decision on January 7, 2015 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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.

FDA 510(k) Submission Details - K142667

510(k) Number K142667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2014
Decision Date January 07, 2015
Days to Decision 110 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 128d · This submission: 110d
Pathway characteristics
Standards-based clearance path.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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.

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