Cleared Traditional

K000672 - HELIODENT VARIO

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

K000672 · Sirona Dental Systems GmbH · Radiology device
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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

Submission Details

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.

Device Classification

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 65
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