Product Classification

• 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 Code: NXC
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT 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
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 4-233 ISO 20795-2 Second edition 2013-03-01
  Dentistry - Base polymers - Part 2: Orthodontic base polymers
• 4-294 ADA ANSI Standard No. 139-2020
  Dental Base Polymers
• 4-295 ADA ANSI Standard No. 41-2020
  Evaluation of Biocompatibility of Medical Devices Used in Dentistry

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc