(63 days)
BioCELLECT™-perio is a bioabsorbable implantable membrane intended for use in the surgical management and treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. It is also used as a membrane that provides a stable barrier for the containment of bone graft material. Its composition allows a relative short term resorption.
BioCELLECT™ is composed of a porous structure of synthetic bioabsorbale compressed L (-)Glycolide homopolymer fibers. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration during wound healing. It is a biocompatible, cell occlusive, clinically manageable device that allows for tissue integration without further surgical intervention.
The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) summary for a medical device called BioCELLECT™-perio, which details its classification, predicate device, and a brief description. The remaining pages are an FDA letter granting substantial equivalence and an "Indications For Use" statement.
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§ 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.