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Teeth, Porcelain

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3920
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.3920 Porcelain tooth

§ 872.3920 Porcelain tooth.

(a) Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.

(b) Classification. Class II.

Teeth, Porcelain

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3920
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.3920 Porcelain tooth

§ 872.3920 Porcelain tooth.

(a) Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.

(b) Classification. Class II.