# K082419: Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1

- Pathway: 510(k) (Abbreviated)
- Applicant: Intra-Lock International, Inc.
- Decided: May 27, 2009 after 278 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K873689 (1987). 52 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071237: Copios Bone Void Filler Sponge and Paste, Kensey Nash Corp. (2007) Summary page 1.
- K040514: Eovia Calcium Phosphate Ceramic, Ortho Tec, LLC (2004) Summary page 1.
- K042706: Ossatura Dental, Isotis Orthobiologics, Inc. (2004) Summary page 1.
- K080308: Bio-Scaffold Bioscaff Alvelac Resobable Scaffold, Bioscaffold International Pte, Ltd. (2008) Summary page 1.
- K060061: Stryker Injectable Cement, Stryker Corp. (2006) Summary page 1.
- K053098: Optium DBM Gel and Putty, Lifenet (2005) Summary page 1.
- K071206: Actifuse Abx E-Z-Fil Putty Bone Graft Substitute, Apatech, Ltd. (2007) Summary page 1.
- K040419: Dynagraft II, Isotis Orthobiologics, Inc. (2005) Summary page 1.

## Most influential descendants
- K101827: Osteoscaf (2011), 1 descendant of its own
- K213260: CMFlexTM (2022), 0 descendants of its own

## Indications for use
ReOss Powder, Putty and Gel are indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

Source page: https://510kreport.com/device/K082419
Methodology: https://510kreport.com/methodology