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510(k) Data Aggregation
K Number
K131385Device Name
EASY-GRAFT
Manufacturer
Degradable Solutions AG
Date Cleared
2013-09-27
(136 days)
Product Code
LYC
Regulation Number
872.3930Why did this record match?
Applicant Name (Manufacturer) :
Degradable Solutions AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 apicoectorny
- Defects after removal of autotogous bone .
Device Description
easy-graft™ contains:
- Syringe containing beta-tricalcium phosphate (β-TCP) granules coated with poly(lactide-co-alvcolide) (PLGA)
- Ampule containing BioLinker™ (N-methyl-2-pyrrolidone and water) .
easy-graft™ is a bioresorbable, synthetic, porous bone graft substitute. It consists of two components: granules (supplied in a syringe) and BioLinker™ (supplied in an ampule). After mixing the components together, easy-graft" forms a moldable mass that can be applied directly from the syringe into the bone defect. easy-graft™ hardens in contact with body fluids, allowing a working time of approximately one minute after application into the bone defect. Depending on · blood inflow, hardening may take longer.
easy-graft™ is provided in the particle sizes of 500 – 630 µm for smaller defects and 500 – 1000 um for larger defects.
easy-graft™ is a biocompatible and osteoconductive material that allows for complete resorption by the body.
easy-graft™ can be used in combination with dental membranes.
easy-graft" contains no animal or human derived substances. β-TCP and PLGA are derived from synthetic raw materials.
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