Cleared Traditional

K032316 - ORION E ALLOY

K032316 is an FDA 510(k) clearance for ORION E ALLOY, manufactured by Dentsply Intl.. The device is a Class 2 Dental device with product code EJT cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K032316 · Dentsply Intl. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
64d
Days
Class 2
Risk

K032316 is an FDA 510(k) clearance for the ORION E ALLOY. Classified as Alloy, Gold-based Noble Metal (product code EJT), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on September 30, 2003 after a review of 64 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply Intl. devices

FDA 510(k) Submission Details - K032316

510(k) Number K032316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2003
Decision Date September 30, 2003
Days to Decision 64 days
Submission Type Traditional
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
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 551
Devices cleared under the same product code (EJT) and FDA review panel - the closest regulatory comparables to K032316.
PORTA SOLDER 1090 W
K040524 · Wieland Dental + Technik GmbH & Co. KG · May 2004
NDX-40 ALLOY
K040043 · Heraeus Kulzer, Inc. · Mar 2004
APPOLLO 3 ALLOY
K032320 · Dentsply International · Oct 2003
ORION GX ALLOY
K032317 · Dentsply Intl. · Sep 2003
MINERVA 58 ALLOY
K032318 · Dentsply International · Sep 2003
CERA R PLUS ALLOY
K032319 · Dentsply International · Sep 2003