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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 Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 872.1810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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