(99 days)
Periophil Biphasic is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil Biphasic can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.
Periophil Biphasic is a bone graft substitute. Periophil Biphasic is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% hydroxyapatite (HA) and 40% beta tricalcium phosphate (B-TCP). Periophil Biphasic is available as granules and is provided sterile for single patient use.
Periophil Biphasic is a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Periophil Biphasic slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. The progressive resorption of Periophil Biphasic resorbable bone filler is intended to prevent premature resorption.
The provided text does not contain information about acceptance criteria, device performance metrics, or a study demonstrating the device meets such criteria. The document is a 510(k) summary for a synthetic bone graft material called "Periophil Biphasic," focusing on its indication for use, product description, and substantial equivalence to a predicate device.
Therefore, I cannot provide the requested table and study details.
§ 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.