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U.S. Department of Health and Human Services

Product Classification

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Device lock, wire, and ligature, intraoral
Regulation Description Intraoral ligature and wire lock.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeDYX
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.4600
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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