Last synced on 30 September 2022 at 11:05 pm

Aligner, Sequential

Page Type
Product Code
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
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.

Aligner, Sequential

Page Type
Product Code
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
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.