(201 days)
The FOUNDATION device is a collagen-based bone filling augmentation material for use in the filling of extraction sockets.
The FOUNDATION device is a collagen-based bone filling augmentation matcrial for use in the filling of extraction sockets with oral maxillofacial defects.
The FOUNDATION device is a sponge-like absorbable natural collagen plug designed to be used as a bone filling material for dental bone defects. The device consists of approximately 85-95% Type I collagen and approximately 5-15% Type III collagen from bovine dermis collagen sources in the United States.
The FOUNDATION device is manufactured in both bullet-shape and in sheets. The device comes in a heat-sealed aluminum package.
Atelocollagen (pepsin solubilized collagen) is purchased from a raw material supplier. Testing is performed to ensure that the telo-peptide has been removed. Protein, excluding collagen, and fat are removed during the extraction process from bovine dermis to atelocollagen at the raw materials supplier's facility. To control antigenicity throughout the manufacturing process, tyrosine moiety is controlled at less than 3/1000. All of the manufacturing of the FOUNDATION device takes place in a "clean room."
The FOUNDATION device is packaged into individual packages and heat-sealed. Quality testing before shipping is performed on the finished devices. The product is physically tested for appearance. Cross-linking is verified by testing to ensure the product maintains its operating characteristics. Sterility tests are also performed.
This document is a 510(k) premarket notification for the "FOUNDATION Bone Filling Augmentation Material" (later referred to as FOUNDATION device). It seeks to demonstrate substantial equivalence to a legally marketed predicate device.
Based on the provided text, the device described is a collagen-based bone filling augmentation material, not an AI/ML powered device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, adjudication methods, and MRMC studies, which are specifically relevant to software-as-a-medical-device (SaMD) or AI/ML-powered devices, are not applicable to this submission.
The document describes a traditional medical device (a collagen plug) and its substantial equivalence to a predicate device. The information provided focuses on the physical characteristics, manufacturing process, and intended use of the material itself.
§ 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.