Last synced on 2 December 2022 at 11:04 pm

Material, Tooth Shade, Resin

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3690
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.3690 Tooth shade resin material

§ 872.3690 Tooth shade resin material.

(a) Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

(b) Classification. Class II.

Material, Tooth Shade, Resin

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3690
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.3690 Tooth shade resin material

§ 872.3690 Tooth shade resin material.

(a) Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

(b) Classification. Class II.