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FDA product code ODU

Facial Implant

General, Plastic SurgeryClass 221 CFR 878.3500Implantable
Verified
US regulatory classifications
US Product Code (FDA)
ODU
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.3500
View CFR Regulation
Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
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.

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01Facial implant02Cosmetic implant03Jaw implant04Cheek implant05Chin implant06Cranial implant07Maxillofacial implant08Aesthetic implant09Reconstructive implant10Bone implant
About this record

Facial Implant is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.