FDA product code NEI: Prosthesis, Condyle, Mandibular, Temporary
NEI is the FDA product code for prosthesis, condyle, mandibular, temporary. It is a Class II device, regulated under 21 CFR 872.4770 and reviewed by the Dental panel. FDA has cleared 7 510(k) submissions under NEI, from 5 different applicants. The average 510(k) review took 310 days (median 238).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Condyle, Mandibular, Temporary |
| Device class | Class II |
| Regulation | 21 CFR 872.4770 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NEI clearance
Top NEI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 3 | 2008-09-05 |
| Stryker | 1 | 2014-04-09 |
| Osteomed LP | 1 | 2004-07-08 |
| Walter Lorenz Surgical, Inc. | 1 | 2001-08-06 |
| KLS-Martin L.P. | 1 | 2001-07-27 |
Most recent NEI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K133285 | Stryker | STRYKER TEMPORARY CONDYLAR PROSTHESIS | 2014-04-09 | 166 |
| K081747 | Synthes (Usa) | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | 2008-09-05 | 78 |
| K063181 | Synthes (Usa) | SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | 2007-01-05 | 78 |
| K031701 | Osteomed LP | OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM | 2004-07-08 | 402 |
| K002790 | Walter Lorenz Surgical, Inc. | ADD-ON CONDYLE | 2001-08-06 | 333 |
Recalls for NEI devices
openFDA lists no recalls for product code NEI.
Frequently asked questions
What is FDA product code NEI?
NEI is the FDA product code for prosthesis, condyle, mandibular, temporary. It is a Class II device, regulated under 21 CFR 872.4770 and reviewed by the Dental panel.
What device class is NEI?
Class II, regulation 21 CFR 872.4770. Typical premarket route: 510(k).
How long does a 510(k) take for product code NEI?
Across 7 cleared submissions the average was 310 days from receipt to decision (median 238).
Which companies have the most NEI clearances?
Synthes (Usa) (3); Stryker (1); Osteomed LP (1); Walter Lorenz Surgical, Inc. (1); KLS-Martin L.P. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NEI
- Run a recall and safety report across every NEI manufacturer
- Watch product code NEI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times