# K131385: Easy-Graft

- Pathway: 510(k) (Traditional)
- Applicant: Degradable Solutions AG
- Decided: Sep 27, 2013 after 136 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: 6 generations back to K954479 (1996). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042583: Calc-I-Oss, Ultradent Products, Inc. (2005) Summary page 2.
- K051443: Cerasorb Dental, Cerasorb M Dental and Cerasorb Perio, Curasan Ag, Frankfurt Facility (2005) Summary page 2.
- K952618: Bio-Oss, Geistlich-Pharma (1995) Summary page 2.
- K970321: Bio-Oss Anorganic Bovine Bone, Geistlich-Pharma (1998) Summary page 2.
- K103815: Q-Station, Philips Ultrasound, Inc. (2011)
- K041324: Calmatrix Calcium Sulfate Bone Graft Binder, Lifecore Biomedical, Inc. (2004) Summary page 3.
- K082383: Fortoss Vital, Biocomposites, Ltd. (2008) Summary page 3.
- K955838: Atrisorb Bioabsorbable Guided Tissue Regneration (GTR), Atrix Laboratories, Inc. (1996) Summary page 3.
- K982865: Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit, Atrix Laboratories, Inc. (1998) Summary page 3.
- K033074: Inion GTR Biodegradable Membrane System, Inion, Ltd. (2004) Summary page 3.

## Indications for use
easy-graft is indicated for the treatment of intraoral / maxillofacial osseous defects. Dental and maxillo-facial indications may include: - Extraction defects (alveolar ridge preservation) - Periodontal defects - Peri-implant defects - Augmentation of deficient alveolar crest (e.g. Guided Bone Regeneration, GBR) - Sinus floor augmentation - Defects after surgical extractions - Defects after removal of bone cysts - Defects after root resection or apicoectomy - Defects after removal of autologous bone

Source page: https://510kreport.com/device/K131385
Methodology: https://510kreport.com/methodology