21 CFR 872.3760 — Resin, Denture, Relining, Repairing, Rebasing

Dental (DE) · Subpart D—Prosthetic Devices · § 872.3760

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
EBIResin, Denture, Relining, Repairing, Rebasing23283rd Party
Innolitics

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