(109 days)
Fortoss-Cema™ is used as a barrier over bone graft materials to prevent particle migration in an osseous defect.
Fortoss-Cema™ is indicated for use as a barrier in placement over bone graft material to r orcess only - barrier and prevent particle migration in an osseous defect.
Fortoss-Cema™ is a medical grade calcium sulfate powder and mixing diluent The blended materials form a creamy paste which set to form a barrier over bone graft materials.
Fortoss-Cema™ is a resorbable pre-measured powder which, when blended with the supplied sterile diluent, forms a setting paste.
I am sorry, but the provided text only contains a 510(k) summary for the Fortoss-Cema™ device, which describes its intended use, design, and substantial equivalence to a predicate device. It does not include information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request for this information.
§ 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.