(261 days)
OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.
OpenTex is a non-resorbable PTFE membrane composed of proprietary 100% polytetrafluoroethylene (PTFE) sheet with inert biological features and predictable barrier effect. OpenTex is designed to function as a physical barrier to avoid gingival cell invasion, thus providing a favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. Since space-making is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse but supple enough to conform easily to tissue contours. OpenTex is supplied sterile and intended for single use only. It is available in various sizes.
This is a 510(k) summary for a medical device called OpenTex, a non-resorbable PTFE membrane for guided tissue regeneration in periodontal defects. The information provided is for regulatory clearance and does not involve AI or algorithms with human-in-the-loop performance. Therefore, many of the requested fields are not applicable.
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1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria | Reported Device Performance (OpenTex) | Predicate Device Performance (Salvin CytoSurg™) | Remarks |
|---|---|---|---|---|---|
| pH | pH measurement test | Difference between blank and extracts |
§ 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.