Cleared Traditional

K050019 - IN EXAM INTRAORAL DENTAL X-RAY SYSTEM

K050019 is an FDA 510(k) clearance for IN EXAM INTRAORAL DENTAL X-RAY SYSTEM, manufactured by Kavo America. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K050019 · Kavo America · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
26d
Days
Class 2
Risk

K050019 is an FDA 510(k) clearance for the IN EXAM INTRAORAL DENTAL X-RAY SYSTEM. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Kavo America (Lake Zurich, US). The FDA issued a Cleared decision on January 31, 2005 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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 Kavo America devices

FDA 510(k) Submission Details - K050019

510(k) Number K050019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2005
Decision Date January 31, 2005
Days to Decision 26 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 136
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K050019.
ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4
K050255 · Gendex Dental Systems · Mar 2005
KODAK ORTHODONTIC IMAGING AND OMS IMAGING 8.0
K043104 · Practiceworks, Inc. · Feb 2005
ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D
K043612 · Instrumentarium Corp. Imaging Division · Feb 2005
MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS
K043557 · Panoramic Corp. · Jan 2005
ELITY 70 X-RAY
K043136 · Dental X-Ray E.U. · Jan 2005
CRANEX D
K043307 · Soredex Palodex Group OY · Dec 2004