Facial Implant
The Facial Implant (product code ODU) is a general and plastic surgery implant used in cosmetic augmentation and correction of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks, as part of plastic and reconstructive surgical procedures. The implants are typically made from biocompatible materials such as silicone elastomer or expanded polytetrafluoroethylene. This device is FDA Class 2 under regulation 878.3500 in the General, Plastic Surgery specialty, requires 510(k) clearance, and carries an implant flag indicating it is surgically placed in the body. It carries no life-sustaining flag.
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Basic Information
- Product Code
- ODU
- Device Class
- FDA class 2
- Regulation Number
- 878.3500
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
Definition
For use in plastic and reconstructive surgery. The devices can be used for cosmetic augmentation and corrections of soft tissue deformities in the face, including areas such as the nose, chin, and cheeks.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K071823 | PERMA FACIAL IMPLANTS | Sep 19, 2007 | Substantially Equivalent | Surgisil |