Cleared Special

K020391 - STERN MICRO ERA ATTACHMENT SYSTEM

K020391 is an FDA 510(k) clearance for STERN MICRO ERA ATTACHMENT SYSTEM, manufactured by Sterngold. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 30-day FDA review.

K020391 · Sterngold · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
30d
Days
Class 2
Risk

K020391 is an FDA 510(k) clearance for the STERN MICRO ERA ATTACHMENT 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 March 8, 2002 after a review of 30 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K020391

510(k) Number K020391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2002
Decision Date March 08, 2002
Days to Decision 30 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 127d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 931
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K020391.
FRIALOC DENTAL IMPLANT SYSTEM
K013067 · Friadent GmbH · Apr 2002
XIVE DENTAL IMPLANT SYSTEM
K013867 · Friadent GmbH · Mar 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020645 · BioHorizons Implant Systems, Inc. · Mar 2002
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
K020096 · Institut Straumann AG · Feb 2002
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
K013891 · Institut Straumann AG · Feb 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020133 · BioHorizons Implant Systems, Inc. · Jan 2002