Bone Grafting Material, Human Source
Dental · 21 CFR 872.3930
INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS. THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BONE, INLCUDING PERIODENTA/INFRABONY DEFECTS; ALVEOLAR RIDGE AUGMENTATION (SINUSOTOMY, OSTEOTOMY, CYSTECTOMY); DENTAL EXTRACTION SITES (RIDGE MAINTENANCE, IMPLANT PREPARATION/PLACEMENT); SINUS LIFTS; CYSTIC DEFECTS; CRANIOFACIAL AUGMENTATION.
Recent MDR events
121 adverse event reports on file
- REGENAVATE® FORMABLE DBM RTJun 26, 2026MalfunctionRti Surgical Inc D.b.a. Evergen3002719998-2026-00010
- REGENAVATE® FORMABLE DBM RTJun 26, 2026MalfunctionRti Surgical, Inc D.b.a Evergen3002719998-2026-00009
- BONE GRAFTING MATERIAL AND PRODUCTApr 1, 2026InjuryRti Surgical, Inc. (dba Rti Biologics, Inc.)MW5186312
- GRAFTON DBMSep 5, 2025InjuryMedtronic Eatontown3002600221-2025-00002
- GRAFTON¿ DBMJul 10, 2025MalfunctionMedtronic Eatontown3002600221-2025-00001
- GRAFTON DBMJul 7, 2025MalfunctionMedtronic Eatontown2246640-2025-00002
- GRAFTON DBMJul 7, 2025MalfunctionMedtronic Eatontown2246640-2025-00003
- GRAFTON¿ DBMMar 27, 2025InjuryMedtronic Eatontown2246640-2025-00001
- GENATE BLENDMar 24, 2025InjuryAce Surgical1287163-2025-01519
- GRAFTON¿ DBFMay 2, 2024InjuryMedtronic Eatontown2246640-2024-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
41 firms currently registered for this product code
Rti Surgical, Inc. (dba Rti Biologics, Inc.)
ALACHUA, FL, US
Isomedix Operations Inc.
CHESTER, NY, US
Zimvie Us Corp Llc
Palm Beach Gardens, FL, US
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Hansamed Limited Dba Citagenix
Mississauga Ontario, CA
Osteotech, Inc.
EATONTOWN, NJ, US
Keystone Dental Inc.
Irvine, CA, US
Hans Biomed Corp.
Daejeon, KR
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Salvin Dental Specialties, Llc
CHARLOTTE, NC, US
Lynx Medical Pennsylvania
ERIE, PA, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Millstone Medical Outsourcing Llc
Olive Branch, MS, US
Etex Corporation
Braintree, MA, US
Zimvie Canada Inc.
Mississauga Ontario, CA
Isomedix Operations, Inc.
Libertyville, IL, US
Musculoskeletal Transplant Foundation D/b/a/ Mtf Biologics
JESSUP, PA, US
Sterigenics U.s. Llc
MULBERRY, FL, US
510(k) clearances
15 clearances for this product code
- Hans Biomed Corp.Jan 10, 2014
K130235 · SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
- Biomet Interpore CrossJan 20, 2012
K113645 · REGENEROSS ALLOGRAFT PLUS MINERLIZED
- Exactech, Inc.Aug 12, 2011
K103699 · EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
- Musculoskeletal Transplant FoundationOct 2, 2009
K091217 · DBX DEMINERALIZED BONE MATRIX PUTTY
- Medtronic Sofamor DanekNov 10, 2008
K082463 · PROGENIX
- Medtronic Sofamor Danek, Inc.Jul 18, 2008
K081950 · PROGENIX PLUS
- Medtronic Sofamor DanekMay 13, 2008
K080462 · PROGENIX DBM PUTTY
- Regeneration Technologies, Inc.Apr 30, 2008
K080418 · REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST