NEI — Prosthesis, Condyle, Mandibular, Temporary Class II
FDA product code NEI covers "Prosthesis, Condyle, Mandibular, Temporary", a Class II medical device regulated under 21 CFR 872.4770. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NEI
- Device Class
- Class II
- Regulation Number
- 872.4770
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K133285 | stryker | STRYKER TEMPORARY CONDYLAR PROSTHESIS | April 9, 2014 |
| K081747 | synthes (usa) | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | September 5, 2008 |
| K063181 | synthes (usa) | SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | January 5, 2007 |
| K031701 | osteomed | OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM | July 8, 2004 |
| K002790 | walter lorenz surgical | ADD-ON CONDYLE | August 6, 2001 |
| K990667 | kls-martin l.p | KLS-MARTIN TEMPORARY CONDYLAR IMPLANT | July 27, 2001 |
| K990637 | synthes (usa) | SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD | October 22, 1999 |