21 CFR 872.3310 — Coating, Filling Material, Resin

Dental (DE) · Subpart D—Prosthetic Devices · § 872.3310

Identification

A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
EBDCoating, Filling Material, Resin2523rd Party
Innolitics

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