Last synced on 23 September 2022 at 11:05 pm

Orthodontic Led Accessory

Page Type
Product Code
Definition
Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Physical State
The system consists of a mouthpiece containing LEDs, software, and battery, and a separate storage/charging station.
Technical Method
The device functions by applying light energy to the tissue surrouding tooth roots for a photobiomodulation effect.
Target Area
Alverolar ridge of maxillary and mandibular arches of patients currently being treated with orthodontic brackets/wires or aligners.
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 Led Accessory

Page Type
Product Code
Definition
Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
Physical State
The system consists of a mouthpiece containing LEDs, software, and battery, and a separate storage/charging station.
Technical Method
The device functions by applying light energy to the tissue surrouding tooth roots for a photobiomodulation effect.
Target Area
Alverolar ridge of maxillary and mandibular arches of patients currently being treated with orthodontic brackets/wires or aligners.
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.