(234 days)
Jason Membrane alone or in combination with suitable augmentation materials (like autogenous bone, allogeneic, xenogeneic or alloplastic bone replacement materials) is indicated for immediate or delayed guided tissue and bone regeneration.
- in case of surgical bone defects and bone wall defects ●
- . in the context of sinus floor augmentation and for support of the Schneiderian membrane
- . in the context of maxillary ridge augmentation
- in the context of maxillary ridge reconstruction for prosthetic treatment
- in the context of a treatment of fenestration defects
- in case of periodontal bone defects (one to three-wall defects, class I and II furcation defects)
- in case of dehiscence defects
- after apicoectomy, cystectomy, resection of retained teeth and resection of other bone lesions
- in extraction sockets after tooth extractions
- . in case of immediate or delayed augmentation around implants in extraction sockets
Jason® Membrane is a completely resorbable collagen membrane used in maxillofacial surgery, implantology, periodontology, oral surgery and endodontology as a barrier membrane to support guided tissue regeneration (GTR) and guided bone regeneration (GBR), for covering implants and for periodontal tissue regeneration. Jason membrane is produced from porcine pericardium in a standardized, controlled purification process. When dry Jason Membrane is a white collagen matrix with a very dense fiber structure. It possesses sufficient rigidity and stability for a broad variety of intended uses. Jason Membrane possesses a physiological neutral pH-value. Jason Membrane typically resorbs within 12 weeks after implantation.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the "Straumann Jason Membrane," detailing its regulatory classification, indications for use, and a comparison to a predicate device. It also lists various performance data that were validated, such as packaging, sterilization, biocompatibility, and shelf life, including an animal study. However, specific acceptance criteria for these tests or the detailed results demonstrating that the device meets them are not provided. Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the other requested details about a study.
§ 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.