21 CFR 872.3910 — Teeth, Artificial, Backing And Facing

Dental (DE) · Subpart D—Prosthetic Devices · § 872.3910

Identification

A backing and facing for an artificial tooth is a device intended for use in fabrication of a fixed or removable dental appliance, such as a crown or bridge. The backing, which is made of gold, is attached to the dental appliance and supports the tooth-colored facing, which is made of porcelain or plastic.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
ELKTeeth, Artificial, Backing And Facing12
Innolitics

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