Cleared Traditional

K760323 - X-RAY UNIT, DENTAL DIAGNOSTIC (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K760323 · The S. S. White Co. · Radiology device
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Aug 1976
Decision
8d
Days
Class 2
Risk

K760323 is an FDA 510(k) clearance for the X-RAY UNIT, DENTAL DIAGNOSTIC. Classified as Unit, X-ray, Intraoral (product code EAP), Class II - Special Controls.

Submitted by The S. S. White Co. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1976 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1810 - 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 The S. S. White Co. devices

Submission Details

510(k) Number K760323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1976
Decision Date August 03, 1976
Days to Decision 8 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 107d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EAP Unit, X-ray, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1810
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.