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U.S. Department of Health and Human Services

Product Classification

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Device aligner, sequential
Regulation Description Orthodontic plastic bracket.
Definition The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.
Physical State Device is composed of a thermoplastic resin. It may also be accompanied by software and/or hardware for patient scanning.
Technical Method Digital scans of patient's dentition are used to create a series of plastic appliances which are intented to progressively move teeth.
Target Area The teeth
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeNXC
Premarket Review Opthalmic, Anaesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5470
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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