COE PAK AUTO MIX, REGULAR OR HARD SET
Device Facts
| Record ID | K881422 |
|---|---|
| Device Name | COE PAK AUTO MIX, REGULAR OR HARD SET |
| Applicant | Coe Laboratories, Inc. |
| Product Code | EMA · Dental |
| Decision Date | Oct 31, 1988 |
| 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.
