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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.

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