# K113049: Socket Graft

- Pathway: 510(k) (Traditional)
- Applicant: Steiner Laboratories
- Decided: Jan 27, 2012 after 106 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- 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
Longest line of descent: 8 generations back to K960978 (1996). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052493: Socket Graft, Steiner Laboratories (2006) Summary page 1.
- K090855: Equivabone Osteoinductive Bone Graft Substitute, Etex Corp. (2009) Summary page 1.
- K041324: Calmatrix Calcium Sulfate Bone Graft Binder, Lifecore Biomedical, Inc. (2004) Summary page 1.
- K974752: Imtec/Biobarrier Membrane, Imtec Corp. (1998) Summary page 1.
- K965205: Tefgen - LS, American Custom Medical, Inc. (1997) Summary page 1.

## Indications for use
SOCKET GRAFT is a bone grafting material indicated for use in dental extraction sockets that have all walls remaining. Socket Seal is' a temporary implantable material intended for use in the oral cavity to be used as a space maintaining barrier over bone and other tissue. Socket Seal is indicated for use over bone grafts. Socket Seal in indicated for use over extraction sockets in the maxilla and mandible.

Source page: https://510kreport.com/device/K113049
Methodology: https://510kreport.com/methodology