(74 days)
IMTEC BioBarrier is a temporarily implantable material intended to be used as a space maintaining barrier over bone. It is intended for use in the oral cavity. The material is conformable to a variety of shapes as required for specific anatomical limitations.
The IMTEC BioBarrier is additionally indicated for:
- simultaneous use of GBR-membrane (BioBarrier) and implants: -
- augmentation around implants placed in immediate extraction sockets; -
- augmentation around implants placed in delayed extraction sockets; -
- localized ridge augmentation for later implantation. 1
Because of its elasticity, the IMTEC BioBarrier should be used in combination with space-making bone graft materials, e.g., autogenous bone or bone substitutes.
IMTEC/BIOBARRIER is a non-absorbable guided tissue membrane composed of 100% Polytetrafluoroethylene. It is provided in various dimensions and can be cut to a preferred shape or size The device will be marketed as a sterile device. It is available in either Porous (5 u) or Non-Porous, "full density" PTFE.
The provided 510(k) summary for the IMTEC/BIOBARRIER MEMBRANE (K974752) does not contain information related to acceptance criteria, device performance, or any studies conducted on the device.
This document primarily focuses on:
- Administrative details: Submitter information, FDA registration, submission dates.
- Device identification: Classification, common name, proprietary name.
- Predicate device: Osteohealth, Bio-gide, K960724.
- Device description: Material composition (100% PTFE), available forms (porous/non-porous), and intended use as a sterile device.
- Indications for Use: Specific applications in oral surgery for guided bone regeneration.
- Principles of Operation: Explains its function as a mechanical barrier.
- Contraindications: Situations where the device should not be used.
- Complications: Potential risks associated with oral reconstructive surgery and the device.
- Materials of Construction: Reiteration of PTFE.
- Comparison of Technological Characteristics: States similarity to predicate devices.
- FDA Correspondence: A letter confirming substantial equivalence to a legally marketed predicate device.
To address your request, information on acceptance criteria and a study proving the device meets them would typically be found in a more comprehensive clinical trial report or a performance data section, which is absent from this specific 510(k) summary.
Therefore, I cannot provide the requested table and study details based on the provided text.
§ 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.