Cleared Abbreviated

K171728 - MOR 3.0mm and PUR NP 3.2mm Implant Systems

K171728 is an FDA 510(k) clearance for MOR 3.0mm and PUR NP 3.2mm Implant Systems, 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 108-day FDA review.

K171728 · Sterngold Dental, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
108d
Days
Class 2
Risk

K171728 is an FDA 510(k) clearance for the MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm. 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 September 28, 2017 after a review of 108 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.

View all Sterngold Dental, LLC devices

FDA 510(k) Submission Details - K171728

510(k) Number K171728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2017
Decision Date September 28, 2017
Days to Decision 108 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
19d faster than avg
Panel avg: 127d · This submission: 108d
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.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 821
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