(251 days)
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
ShefaBone SCPC Resorbable Bioactive Bone Graft, is a silica-calcium phosphate composite, synthetic bone graft material. It is resorbable and has a porous structure with a particle size of 90-710 micron. It is processed by thermal treatment to bond the chemical components together. It is packaged in a sealed glass vial containing 1 gm (1cc) of SCPC particles, sealed in an aluminum sterilization pouch, and sterilized by Gama radiation.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance. The document is a 510(k) premarket notification approval letter for a medical device (ShefaBone SCPC Resorbable Bone Graft) and includes a summary comparing it to a predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.