(110 days)
DSM Biomedical Dental Bone Graft is indicated for:
- Augmentation or reconstructive treatment of the alveolar ridge
- Filling of infrabony periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of the maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
The DSM Biomedical Dental Bone Graft is a non-pyrogenic porous bone mineral matrix for use in periodontal, oral, and maxillofacial surgery. It is produced by removing organic components from porcine bone. The composition of DSM Biomedical Dental Bone Graft meets the requirements of ASTM F 1581 Standard Specification for Composition of Anorganic Bone for Surgical Implants. The device is provided as cancellous granules approximately 0.25 - 1.0mm in size. It is supplied sterile by gamma irradiation and is for single use only.
The provided text is a 510(k) summary for the DSM Biomedical Dental Bone Graft. It describes the device, its indications for use, and a comparison to a predicate device (Bio-OSS®). However, this document does not contain the acceptance criteria or a study proving that an AI device meets acceptance criteria.
Instead, it pertains to a traditional medical device (a dental bone graft material) and focuses on demonstrating substantial equivalence to a predicate device through material characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device's performance based on the provided text. The document does not describe an AI device.
§ 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.