(513 days)
The BBP™ Bone Substitute is a bone filling augmentation material used for augmentation or reconstruction of the alveolar ridge, filling of periodontal bony defects, and filling of extraction sockets to enhance preservation of alveolar ridge.
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This document is a 510(k) clearance letter from the FDA for a medical device called "BBP™ Bone Substitute." It does not contain information about acceptance criteria or a study proving its performance.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory aspects like registration, labeling, and manufacturing practices, but does not include any performance data or study details.
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§ 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.