FDA Product Code
FDA Product Code NEA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3275
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K140644 | PROCEM | Ototronix, LLC | 2014-06-19 | Traditional | PDF ↗ |
| K080032 | ENVOYCEM, MODEL 1640 | Envoy Medical Corporation | 2008-02-28 | Traditional | PDF ↗ |
| K060750 | STRYKER INJECTABLE CEMENT | Stryker Cmf | 2006-04-19 | Traditional | PDF ↗ |
| K042516 | OTOMIMIX | Walter Lorenz Surgical, Inc. | 2004-11-08 | Traditional | PDF ↗ |
| K011338 | OTO-CEM | Ototech, Inc. | 2001-09-13 | Traditional | PDF ↗ |
| K003567 | SERENOCEM, MODEL BC 010 | Corinthian Medical , Ltd. | 2001-02-12 | Traditional | PDF ↗ |
Product code NEA · Class II · Dental. Data: openFDA.