ODUClass IIImplant
Facial Implant
General, Plastic Surgery · 21 CFR 878.3500
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.
MDR events10All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances1All time
Recent MDR events
10 adverse event reports on file
- ENDOTINEJun 19, 2026InjuryMicroaire Surgical Instruments2020601-2026-00005
- ENDOTINE FOREHEAD 3.5May 27, 2026MalfunctionMicroaire Surgical Instruments2020601-2026-00004
- MICROAIRE ENDOTINEFeb 3, 2023MalfunctionMicroaire Surgical Instruments, Llc2020601-2023-00001
- MICROAIRE ENDOTINEFeb 3, 2023MalfunctionMicroaire Surgical Instruments, Llc2020601-2023-00002
- MICROAIRE ENDOTINEOct 18, 2022MalfunctionMicroaire Surgical Instruments, Llc2020601-2022-00007
- MICROAIRE ENDOTINEJun 29, 2022MalfunctionMicroaire Surgical Instruments, Llc2020601-2022-00002
- MICROAIRE ULTRATINEFeb 11, 2022MalfunctionMicroaire Surgical Instruments, Llc2020601-2022-00001
- MICROAIRE ENDOTINEMay 20, 2021MalfunctionMicroaire Surgical Instruments, Llc2020601-2021-00002
- MICROAIRE ENDOTINEFeb 19, 2021MalfunctionMicroaire Surgical Instruments2020601-2021-00001
- BLT Ø2.9MM SC, SLACTIVE® 12MM, RXD, LOXIJul 31, 2018InjuryInstitut Straumann Ag1222315-2018-00430
Event type breakdown
Malfunction8
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
1 clearances for this product code