Cleared Traditional

K000428 - DIXI 2

K000428 is an FDA 510(k) clearance for DIXI 2, manufactured by Planmeca Oy. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K000428 · Planmeca Oy · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
79d
Days
Class 2
Risk

K000428 is an FDA 510(k) clearance for the DIXI 2. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on April 28, 2000 after a review of 79 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 Planmeca Oy devices

FDA 510(k) Submission Details - K000428

510(k) Number K000428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2000
Decision Date April 28, 2000
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
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 78
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K000428.
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · Planmeca Oy · Jun 2001
DIMAX 2
K000771 · Planmeca Oy · May 2000
HELIODENT VARIO
K000672 · Sirona Dental Systems GmbH · May 2000
PM 2002 PROLINE/AEC
K000163 · Planmeca Oy · Apr 2000
ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH
K994285 · Dentsply Intl. · Mar 2000
GENDEX 765DC, MODEL 110-0154
K992610 · Dentsply Intl. · Sep 1999