(74 days)
MBCP Gel™ is intended for use as a bone grafting material to fill, augment or reconstruct osseous bone defects in particular in periodontal or oral/maxillofacial applications.
These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
MBCP Gel™ can generally be used for bone filling in closed cavities.
MBCP Gel™ can be used with autogenous bone grafting materials.
Typical uses include but are not limited to:
- . Periodontal/Infrabony defects
- Ridge augmentation .
- Extraction sites (implant preparation/placement) .
- . Sinus lifts
- Cystic cavities .
MBCP Gel™ is a Resorbable Bone Graft Substitute that is rapidly replaced by newly-formed bone. This material is a non self setting gel providing mechanical resistance after healing and osseous rehabilitation.
MBCP Gel™ is composed of biphasic Calcium Phosphate (60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (beta-TCP)) particles associated with an excipient with pharmaceutical grade quality (hydroxypropylmethylcellulose in an aqueous solution). The carrier acts as a spacer and a binder of the particles. MBCP Gel™ provides an environment for bone ingrowth. On time MBCP Gel™ is fully resorbable.
MBCP Gel™ is provided sterile for single patient use in a syringe.
This document is a 510(k) Summary of Safety and Effectiveness for the MBCP Gel™ device. It outlines the general information, predicate devices, device description, and intended use. However, it does not contain information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as requested.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria, as this information is not present in the provided text.
The document primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting detailed performance study results against specific criteria.
§ 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.