Cleared Traditional

K932111 - DENTAL X-RAY UNIT

K932111 is an FDA 510(k) clearance for DENTAL X-RAY UNIT, manufactured by Castellini S.P.A.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K932111 · Castellini S.P.A. · Radiology device
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Jan 1994
Decision
267d
Days
Class 2
Risk

K932111 is an FDA 510(k) clearance for the DENTAL X-RAY UNIT. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Castellini S.P.A. (Italy, IT). The FDA issued a Cleared decision on January 25, 1994 after a review of 267 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Castellini S.P.A. devices

FDA 510(k) Submission Details - K932111

510(k) Number K932111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1993
Decision Date January 25, 1994
Days to Decision 267 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 107d · This submission: 267d
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 124
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