Cleared Traditional

K960028 - ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM

K960028 is an FDA 510(k) clearance for ORTHORALIX SD2 & S PANORAMIC DENTAL X-R..., manufactured by Dentsply Intl.. The device is a Class 2 Radiology device with product code EAP cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K960028 · Dentsply Intl. · Radiology device
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Mar 1996
Decision
59d
Days
Class 2
Risk

K960028 is an FDA 510(k) clearance for the ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on March 1, 1996 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - the FDA radiology and imaging software oversight 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 - K960028

510(k) Number K960028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date March 01, 1996
Days to Decision 59 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EAP Device Classification - Class 2, Special Controls

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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 Radiology devices follow this clearance model.

Regulatory Peers - EAP Unit, X-ray, Intraoral

All 12
Devices cleared under the same product code (EAP) and FDA review panel - the closest regulatory comparables to K960028.
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
K052422 · Flow X-Ray Corp. · Sep 2005
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM
K041385 · Schick Technologies, Inc. · Jun 2004
HELIODENT DS
K960819 · Pelton & Crane Co. · Mar 1996
ATLANTIS
K953936 · Trophy Radiologie · Dec 1995
TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY
K950533 · Trophy Radiologie · Jun 1995
TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY
K950532 · Trophy Radiologie · Apr 1995