OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT
Device Facts
| Record ID | K801779 |
|---|---|
| Device Name | OXYDENTAL ZINC OXIDE EUGENOL(ZOE)CEMENT |
| Applicant | Oxy Dental Products, Inc. |
| Product Code | EMB · Dental |
| Decision Date | Aug 7, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3275 |
| Device Class | Class 1 |
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.
