Last synced on 2 December 2022 at 11:04 pm

Adhesive, Bracket And Tooth Conditioner, Resin

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3750
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.3750 Bracket adhesive resin and tooth conditioner

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a) Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

(b) Classification. Class II.

Adhesive, Bracket And Tooth Conditioner, Resin

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3750
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.3750 Bracket adhesive resin and tooth conditioner

§ 872.3750 Bracket adhesive resin and tooth conditioner.

(a) Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.

(b) Classification. Class II.