Cleared Abbreviated

K020949 - APOLLO, MODEL 1124525

K020949 is an FDA 510(k) clearance for APOLLO, manufactured by Sterngold. The device is a Class 2 Dental device with product code EJT cleared through the Abbreviated 510(k) pathway after a 10-day FDA review.

K020949 · Sterngold · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
10d
Days
Class 2
Risk

K020949 is an FDA 510(k) clearance for the APOLLO, MODEL 1124525. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Sterngold (Attleboro, US). The FDA issued a Cleared decision on April 4, 2002 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3060 - 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 - K020949

510(k) Number K020949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2002
Decision Date April 04, 2002
Days to Decision 10 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
118d faster than avg
Panel avg: 128d · This submission: 10d
Pathway characteristics
Standards-based clearance path.

EJT Device Classification - Class 2, Special Controls

Product Code EJT Alloy, Gold-based Noble Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3060
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 - EJT Alloy, Gold-based Noble Metal

All 620
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K020949.
CRITERTION, MODEL #1067511
K021741 · Sterngold · Jun 2002
PORTALLOY 54
K021242 · Wieland Dental + Technik GmbH & Co. KG · May 2002
AGC SPEZIALLEGIERUNG
K020347 · Wieland Edelmetalle GmbH & Co. · Apr 2002
PORTADUR P 4
K020190 · Wieland Dental + Technik GmbH & Co. KG · Mar 2002
V-GNATHOS SUPRA
K013769 · Metalor Technologies USA · Jan 2002
YELLOW SPECIAL
K013506 · Metalor Technologies USA · Jan 2002
K020949 · APOLLO, MODEL 1124525
Download PDF FDA Summary Sterngold