Bone Grafting Material, Dental, With Biologic Component
Dental · 21 CFR 872.3930
Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.
Recent MDR events
235 adverse event reports on file
- GENATE BLEND CORTICO AND CANCELLOUSOct 20, 2023InjuryRegenx1287163-2023-01234
- GENATE BLEND CORTICO AND CANCELLOUSOct 20, 2023InjuryRegenx1287163-2023-01239
- GENATE BLEND CORTICO AND CANCELLOUSOct 20, 2023InjuryRegenx1287163-2023-01238
- GENATE BLEND CORTICO AND CANCELLOUSOct 20, 2023InjuryRegenx1287163-2023-01236
- GENATE BLEND CORTICO AND CANCELLOUSOct 20, 2023InjuryRegenx1287163-2023-01235
- GENATE BLEND CORTICO AND CANCELLOUSOct 20, 2023InjuryRegenx1287163-2023-01237
- GENATE BLEND CORTICO AND CANCELLOUSOct 20, 2023InjuryRegenx1287163-2023-01243
- GENATE BLEND CORTICO AND CANCELLOUSOct 20, 2023InjuryRegenx1287163-2023-01244
- GENATE BLEND CORTICO AND CANCELLOUSOct 20, 2023InjuryRegenx1287163-2023-01245
- GENATE BLEND CORTICO AND CANCELLOUSOct 20, 2023InjuryRegenx1287163-2023-01242
Event type breakdown
Registered firms
7 firms currently registered for this product code
Sterigenics Us Llc
Gurnee, IL, US
A+ Secure Packaging
La Vergne, TN, US
Lynch Biologics Llc
Franklin, TN, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Altasciences Cdmo Philadelphia, Llc
Harleysville, PA, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
3 premarket approvals for this product code