# K080418: Regenafil, Regenaform, Alriva DBM Paste, Sltiva DM with Cortical Cancellous Ships, Bioset, Sioset IC, Rti Allograft Past

- Pathway: 510(k) (Traditional)
- Applicant: Regeneration Technologies, Inc.
- Decided: Apr 30, 2008 after 75 days
- Product code: NUN (Bone Grafting Material, Human Source)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GRAFTON PLUS® DBM Paste: named in the summary without a submission number
- (no number) Grafton® DBM: named in the summary without a submission number
- (no number) Accell Connexus: named in the summary without a submission number
- (no number) DBX® Demineralized Bone Matrix: named in the summary without a submission number
- (no number) RTI Allograft Paste: named in the summary without a submission number
- (no number) RTI Allograft Paste IC: named in the summary without a submission number

## Indications for use
These products are 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 created osseous defects or osseous defects created from traumatic injury to the bone, including * Periodontal defects; · Alveolar ridge augmentation; · Extraction sockets (ridge preservation, implant preparation/ placement); · Maxillary sinus floor elevation; · Craniofacial augmentation; · Root resection, apicoectomy and cystectomy; * Tumor resection. One or more of the product formulations, depending upon specific anatomical location and physician and/or dentist preference, can be placed in the dental intraosseous defect site.

Source page: https://510kreport.com/device/K080418
Methodology: https://510kreport.com/methodology