COMPUTED ORAL RADIOLOGY SYSTEM

K933455 · Schick Technologies, Inc. · EAP · Jan 31, 1994 · Dental

Device Facts

Record IDK933455
Device NameCOMPUTED ORAL RADIOLOGY SYSTEM
ApplicantSchick Technologies, Inc.
Product CodeEAP · Dental
Decision DateJan 31, 1994
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.1810
Device ClassClass 2

Regulatory Classification

Identification

An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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