(161 days)
Norian PDC is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall.
Norian PDC Cement is intended to be used in the treatment of periodontal bone wall defects, extraction socket defects, and for repair of cysts or other defects in the alveolar ridge or wall.
Norian PDC is a paste-like bone cement which is intended to fill and/or augment periodontal bone wall defects, extraction socket defects, and cysts or other defects in the alveolar ridge or wall. Norian PDC is an injectable and moldable, biocompatible, bone cement. The Norian PDC Reactants Pack contains the two sterile components used in Norian PDC: Calcium Phosphate Powder and Sodium Phosphate Solution. The Reactants Pack is mixed in a pneumatic mixer to form a smooth, viscous paste which is applied to the operative site. Norian PDC cures into a carbonated apatite that is substantially similar to the mineral component of bone, and over time, the Norian PDC is gradually resorbed over time.
The provided text is a 510(k) summary for the Norian® PDC™ bone cement. It describes the device, its intended use, and device testing. However, it does not contain the detailed information needed to answer the specific questions about acceptance criteria for a device's performance, a specific study proving it, or AI/human reader performance.
The document states: "Biocompatibility testing showed that Norian PDC Cement is acceptable for its intended use as a bone implant material. Norian Cement passed all tests, and showed no toxic, mutagenic or irritating effect." This is a general statement about meeting biocompatibility requirements, not specific performance metrics (like accuracy, sensitivity, specificity) for a diagnostic or AI-based device, nor details of a study with human readers.
Therefore, I cannot provide the requested information based on the provided text. The questions are geared towards the evaluation of AI/diagnostic devices, which is not the subject of this 510(k) summary for a bone cement.
§ 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.