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U.S. Department of Health and Human Services

Product Classification

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Device indirect bonding tray
Regulation Description Orthodontic appliance and accessories.
Definition A tray or splint to enable bonding of multiple orthodontic brackets to tooth surfaces.
Physical State Solid thermoplastic
Technical Method Brackets are aligned on a stone model. The tray or splint is formed over the model and is placed intraorally in the patient. After bonding of the brackets, the tray or splint is lifted and discarded.
Target Area Intraoral
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeQJJ
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(K) Exempt
Regulation Number 872.5410
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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