(27 days)
The intended use of NovaBone Dental Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include:
- · Periodontal/Infrabony defects
- · Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
- · Extraction (ridge maintenance/augmentation, implant preparation/ sites placement)
- · Sinus lifts
- · Cystic cavities
- · Cranio-facial augmentation
For larger defects, a mixture of NovaBone Dental Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.
NovaBone Dental Putty is an osteoconductive, bone void filler device. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects and is supplied sterile. It is composed of a calcium-phosphorussodium-silicate (Bioglass) particulate mixed with a synthetic binder that acts as a temporary binding agent for the particulate. The particulate and binder are provided premixed as a pliable cohesive material. The mixed device is supplied sterile, packaged either in a PET-G tray or in a disposable plastic syringe. On implantation, the binder is absorbed to permit tissue infiltration between the Bioglass particles. The particles are slowly absorbed and replaced by new bone tissue during the healing process. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects. It is supplied sterile.
This document (K091484) is a Special 510(k) for a device modification involving a change in package format for NovaBone Dental Putty – Bioactive Synthetic Bone Graft. It is not a clinical study report and therefore does not contain the information requested regarding acceptance criteria and device performance data from a study.
Specifically, the document focuses on demonstrating substantial equivalence of a new syringe package format to existing predicate devices, rather than presenting a study design with acceptance criteria and results. The content states that the "device modification does not result in a change in technological characteristics of the device" and that "NovaBone Putty continues to be safe and effective as a non-structural osteoconductive bone void filler for osseous defects," implying reliance on prior clearances and the predicate device's established safety and effectiveness.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or grand truth details from this specific document. These types of details would typically be found in a clinical study report or a more comprehensive premarket submission that involves new performance claims requiring clinical validation.
§ 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.