Cleared Traditional

K093683 - ORTHOPANTOMOGRAPH OP300

K093683 is an FDA 510(k) clearance for ORTHOPANTOMOGRAPH OP300, manufactured by Instrumentarium Dental, Palodex Group OY. The device is a Class 2 Radiology device with product code MUH cleared through the Traditional 510(k) pathway after a 310-day FDA review.

K093683 · Instrumentarium Dental, Palodex Group OY · Radiology device
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Oct 2010
Decision
310d
Days
Class 2
Risk

K093683 is an FDA 510(k) clearance for the ORTHOPANTOMOGRAPH OP300. Classified as System, X-ray, Extraoral Source, Digital (product code MUH), Class II - Special Controls.

Submitted by Instrumentarium Dental, Palodex Group OY (Tuusula, FI). The FDA issued a Cleared decision on October 6, 2010 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Instrumentarium Dental, Palodex Group OY devices

FDA 510(k) Submission Details - K093683

510(k) Number K093683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2009
Decision Date October 06, 2010
Days to Decision 310 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 107d · This submission: 310d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUH Device Classification - Class 2, Special Controls

Product Code MUH System, X-ray, Extraoral Source, Digital
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 - MUH System, X-ray, Extraoral Source, Digital

All 97
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