Prosthetic devices · 21 CFR 872 Subpart D
Nose and Throat Ear Cement
FDA device type “Cement, Ear, Nose And Throat”.
- Companies listing it
- 83 makers
- Brands and models
- 7
- 510(k) clearances
- 60 in five years
- FDA name
- Cement, Ear, Nose And Throat
510(k) clearances per year, 1976–2026
Companies that list NEA
8 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Biomet Microfixation | United States | Maker | OTOMIMIX | 8 | 2021 |
| Envoy Medical Corporation | United States | Maker | EnvoyCem | 1 | 2008 |
| Ototronix, LLC | United States | Maker | ProCem | 1 | 2014 |
| Olympus Corporation | Japan | Foreign exporter | Otomimix Otologic cement | 1 | 2007 |
| Sotera Health LLC | United States | Contract manufacturer | Otomimix | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Midwest Sterilization Corp. | United States | Contract sterilizer | Otomimix otologic cement | — | — |
| 美国英泰国际公司Invotec International Inc. | United States | Repacker / relabeler | SerenoCem Otologic Bone Cement | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 19 Jun 2014 | K140644 | PROCEM | Ototronix, LLC |
| 28 Feb 2008 | K080032 | ENVOYCEM, MODEL 1640 | Envoy Medical Corporation |
| 19 Apr 2006 | K060750 | STRYKER INJECTABLE CEMENT | Stryker Cmf |
| 8 Nov 2004 | K042516 | OTOMIMIX | Walter Lorenz Surgical, Inc. |
| 13 Sep 2001 | K011338 | OTO-CEM | Ototech, Inc. |
| 12 Feb 2001 | K003567 | SERENOCEM, MODEL BC 010 | Corinthian Medical , Ltd. |
Official records: FDA product classification for NEA · 21 CFR 872.3275.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026