# K153230: ShefaBone SCPC Resorbable Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: The Implantech Inc./Shefabone
- Decided: Jul 14, 2016 after 251 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: 3 generations back to K941780 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040278: Perioglas-Bioglass Bone Graft Substitute, Novabone Products, LLC (2004) Summary page 5.

## Indications for use
ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. Typical uses include: • Periodontal / infrabony defects • Ridge augmentation (sinusotomy, osteotomy, cystectomy) • Extraction sites (ridge maintenance/augmentation, implant preparation/ placement) • Sinus lifts • Cystic cavities • Oral and maxillofacial augmentation

Source page: https://510kreport.com/device/K153230
Methodology: https://510kreport.com/methodology