Cleared Traditional

K000672 - HELIODENT VARIO

K000672 is an FDA 510(k) clearance for HELIODENT VARIO, manufactured by Sirona Dental Systems GmbH. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K000672 · Sirona Dental Systems GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
64d
Days
Class 2
Risk

K000672 is an FDA 510(k) clearance for the HELIODENT VARIO. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Sirona Dental Systems GmbH (North Attleboro, US). The FDA issued a Cleared decision on May 2, 2000 after a review of 64 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 Sirona Dental Systems GmbH devices

FDA 510(k) Submission Details - K000672

510(k) Number K000672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2000
Decision Date May 02, 2000
Days to Decision 64 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
43d faster than avg
Panel avg: 107d · This submission: 64d
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 K000672.
PROMAX, PANORAMIC X-RAY UNIT WITH CEPHALOSTAT
K011619 · Planmeca Oy · Jun 2001
FOCUS
K001729 · Instrumentarium Corp. · Jul 2000
DIMAX 2
K000771 · Planmeca Oy · May 2000
DIXI 2
K000428 · Planmeca Oy · Apr 2000
PM 2002 PROLINE/AEC
K000163 · Planmeca Oy · Apr 2000
MINXRAY HF70D HIGH FREQUENCY PORTABLE DENTAL X-RAY UNIT
K000061 · Minxray, Inc. · Apr 2000