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U.S. Department of Health and Human Services

Product Classification

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Device unit, x-ray, intraoral
Regulation Description Intraoral source x-ray system.
Regulation Medical Specialty Dental
Review Panel Radiology
Product CodeEAP
Premarket Review Division of Radiological Health (DRH)
Division of Radiological Health (DRH)
Submission Type 510(k)
Regulation Number 872.1810
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
Third Party Review
Accredited Persons
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