Last synced on 27 January 2023 at 11:04 pm

Orthodontic Software

Page Type
Product Code
Definition
The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.
Physical State
Software which may produce an orthodontic appliance
Technical Method
May use software, scanning equipment, CAD/CAM, and printing machines for the fabrication of orthodontic appliances
Target Area
Intraoral
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 Software

Page Type
Product Code
Definition
The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.
Physical State
Software which may produce an orthodontic appliance
Technical Method
May use software, scanning equipment, CAD/CAM, and printing machines for the fabrication of orthodontic appliances
Target Area
Intraoral
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.