Who is the manufacturer of CLASSIC CEM?

S & C Polymer GmbH submitted the Traditional clearance for CLASSIC CEM (K011064).

What is the FDA product code for CLASSIC CEM?

EMA. It is classified under 21 CFR 872.3275 as a Class 2 device in the Dental panel.

What is the regulatory pathway for CLASSIC CEM?

510(k) clearance (submission type: Traditional).

CLASSIC CEM

K011064 · S & C Polymer GmbH · EMA · May 17, 2001 · Dental

Device Facts

Record ID	K011064
Device Name	CLASSIC CEM
Applicant	S & C Polymer GmbH
Product Code	EMA · Dental
Decision Date	May 17, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3275
Device Class	Class 2

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.