NEI · Prosthesis, Condyle, Mandibular, Temporary
Dental · 21 CFR 872.4770 · Class 2
Overview
| Product Code | NEI |
|---|---|
| Device Name | Prosthesis, Condyle, Mandibular, Temporary |
| Regulation | 21 CFR 872.4770 |
| Device Class | Class 2 |
| Review Panel | Dental |
| Implant | Yes |
Identification
A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.
Classification Rationale
Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.
Cleared Devices (7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K133285 | STRYKER TEMPORARY CONDYLAR PROSTHESIS | Stryker | Apr 9, 2014 | SESE |
| K081747 | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) | Sep 5, 2008 | SESE |
| K063181 | SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) | Jan 5, 2007 | SESE |
| K031701 | OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM | Osteomed LP | Jul 8, 2004 | SESE |
| K002790 | ADD-ON CONDYLE | Walter Lorenz Surgical, Inc. | Aug 6, 2001 | SESE |
| K990667 | KLS-MARTIN TEMPORARY CONDYLAR IMPLANT | KLS-Martin L.P. | Jul 27, 2001 | SESE |
| K990637 | SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD | Synthes (Usa) | Oct 22, 1999 | SESE |
Top Applicants
- Synthes (Usa) — 3 clearances
- Walter Lorenz Surgical, Inc. — 1 clearance
- Stryker — 1 clearance
- Osteomed LP — 1 clearance
- KLS-Martin L.P. — 1 clearance
