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U.S. Department of Health and Human Services

Product Classification
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Device screw, fixation, intraosseous
Regulation Description Intraosseous fixation screw or wire.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeDZL
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.4880
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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