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U.S. Department of Health and Human Services

Product Classification

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Device unit, x-ray, extraoral with timer
Regulation Description Extraoral source x-ray system.
Regulation Medical Specialty Dental
Review Panel Radiology
Product CodeEHD
Premarket Review Office of Radiological Health (OHT8)
Radiological Imaging Devices and Electronic Products (DHT8B)
Submission Type 510(k)
Regulation Number 872.1800
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standards
Guidance Document
Third Party Review
Accredited Persons
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