MZW · Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Dental · 21 CFR 872.3275 · Class 2
Overview
| Product Code | MZW |
|---|---|
| Device Name | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief |
| Regulation | 21 CFR 872.3275 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Zinc oxide-eugenol: Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9. Dental cement other than zinc oxide-eugenol: Class II.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K073209 | MAXCEM 2 | Kerr Corporation | Jan 29, 2008 | SESE |
| K991923 | SOOTHE-N-SEAL CANKER SORE RELIEF | Closure Medical Corp. | Sep 2, 1999 | SESE |
Top Applicants
- Kerr Corporation — 1 clearance
- Closure Medical Corp. — 1 clearance
