Cleared Abbreviated

K041271 - STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM

K041271 is an FDA 510(k) clearance for STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM, manufactured by Sterngold. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 169-day FDA review.

K041271 · Sterngold · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
169d
Days
Class 2
Risk

K041271 is an FDA 510(k) clearance for the STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sterngold (Ayer, US). The FDA issued a Cleared decision on October 28, 2004 after a review of 169 days - an extended review cycle.

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 - K041271

510(k) Number K041271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2004
Decision Date October 28, 2004
Days to Decision 169 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 128d · This submission: 169d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K041271.
BICONITE SURFACE TREATMENT
K031568 · Bicon, Inc. · Nov 2004
THE 5.0 X 6.0MM DENTAL IMPLANT
K042637 · Bicon, Inc. · Nov 2004
NEOPLANT IMPLANT SYSTEM
K042339 · Neobiotech Co., Ltd. · Nov 2004
FRIADENT PLUS DENTAL IMPLANT SYSTEMS
K040170 · Friadent GmbH · Oct 2004
MODIFICATION TO SILHOUETTE IC OR SILHOUETTE
K041136 · Bio-Lok Intl., Inc. · Oct 2004
STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM
K041651 · Stryker Leibinger · Sep 2004
K041271 · STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Sterngold