(164 days)
MBCP+™ is intended for use as a bone grafting material to fill, augment or reconstruct periodontal or bony defects of the oral and maxillofacial region.
These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP+™ can be used with autogenous bone grafting materials.
Typical uses include:
- Periodontal/Infrabony defects
- Ridge augmentation
- Extraction sites (implant preparation/placement)
- Sinus lifts
- Cystic cavities
MBCP+™ is a bone graft material used in dental applications. The MBCP+™ product consists of a biphasic ceramic (e.g hydroxyapatite and tricalcium phosphate beta). MBCP+™ dental product is a synthetic device, available in different sizes of granules. MBCP+™ product is available sterile for single use.
This document is a 510(k) premarket notification for a bone grafting material, MBCP+™. It establishes substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document primarily focuses on:
- Device identification: Product name (MBCP+™), classification, product code, and relevant regulations.
- Intended use: Description of dental applications for which MBCP+™ is intended.
- Comparison to predicate devices: Stating that it has the same intended use, principle of operation, and similar technological characteristics to listed predicate devices (OsSatura™, Cerasorb™ Dental, MBCP™).
- Non-clinical performance data: Mentioning that testing was performed according to the "Guidance Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices" to support substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies demonstrating that the device meets them, as this specific document does not contain that level of detail. It simply states that non-clinical performance data supports substantial equivalence based on regulatory guidance for dental bone grafting materials. There are no performance metrics, sample sizes, ground truth information, or multi-reader studies described in this filing.
§ 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.