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U.S. Department of Health and Human Services

Product Classification

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Device tester, pulp
Regulation Description Pulp tester.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeEAT
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type 510(k)
Regulation Number 872.1720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review
Accredited Persons

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