Cleared Abbreviated

K092434 - STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM

K092434 is an FDA 510(k) clearance for STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL..., manufactured by Sterngold. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 95-day FDA review.

K092434 · Sterngold · Dental device
Download Printable Device Report (PDF)
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Nov 2009
Decision
95d
Days
Class 2
Risk

K092434 is an FDA 510(k) clearance for the STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sterngold (Attleboro, US). The FDA issued a Cleared decision on November 10, 2009 after a review of 95 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 devices

FDA 510(k) Submission Details - K092434

510(k) Number K092434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2009
Decision Date November 10, 2009
Days to Decision 95 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
32d faster than avg
Panel avg: 127d · This submission: 95d
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 930
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