NEA · Cement, Ear, Nose And Throat
Dental · 21 CFR 872.3275 · Class 2
Overview
| Product Code | NEA |
|---|---|
| Device Name | Cement, Ear, Nose And Throat |
| Regulation | 21 CFR 872.3275 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K140644 | PROCEM | Ototronix, LLC | Jun 19, 2014 | SESE |
| K080032 | ENVOYCEM, MODEL 1640 | Envoy Medical Corporation | Feb 28, 2008 | SESE |
| K060750 | STRYKER INJECTABLE CEMENT | Stryker Cmf | Apr 19, 2006 | SESE |
| K042516 | OTOMIMIX | Walter Lorenz Surgical, Inc. | Nov 8, 2004 | SESE |
| K011338 | OTO-CEM | Ototech, Inc. | Sep 13, 2001 | SESE |
| K003567 | SERENOCEM, MODEL BC 010 | Corinthian Medical , Ltd. | Feb 12, 2001 | SESE |
Top Applicants
- Walter Lorenz Surgical, Inc. — 1 clearance
- Stryker Cmf — 1 clearance
- Ototronix, LLC — 1 clearance
- Ototech, Inc. — 1 clearance
- Envoy Medical Corporation — 1 clearance
