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Orthodontic Vibratory Accessory

Page Type
Product Code
Definition
An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
Physical State
The system consists of four components: The Activator, Mouthpiece, Charging Port, and Travel Shell.
Technical Method
The device functions by providing vibration to the teeth. This is done for 20 minutes a day per the length of the entire treatment.
Target Area
Patients with "separate canine retraction" and "en masse" retraction.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.5470
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.5470 Orthodontic plastic bracket

§ 872.5470 Orthodontic plastic bracket.

(a) Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

(b) Classification. Class II.

Orthodontic Vibratory Accessory

Page Type
Product Code
Definition
An orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
Physical State
The system consists of four components: The Activator, Mouthpiece, Charging Port, and Travel Shell.
Technical Method
The device functions by providing vibration to the teeth. This is done for 20 minutes a day per the length of the entire treatment.
Target Area
Patients with "separate canine retraction" and "en masse" retraction.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.5470
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.5470 Orthodontic plastic bracket

§ 872.5470 Orthodontic plastic bracket.

(a) Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

(b) Classification. Class II.