(113 days)
Geistlich Combi-Kit Collagen is a convenience kit that provides one (1) unit Gelstich and seatings Collagen membrane and one (1) unit Geistlich Bio-Oss Collagen® block in one (1) package.
Geistlich Bio-Gide® is intended for the following uses:
- Augmentation around implants placed in immediate extraction sockets;
- Augmentation around implants placed in delayed extraction sockets;
- Localized ridge augmentation for later implantation;
- Alveolar ridge reconstruction for prosthetic treatment;
- Filling of bone defects after root resection, cystectorny, removal of retained teeth;
- Guided bone regeneration in dehiscence defects; and
- Guided tissue regeneration procedures in periodontal defects.
Geistlich Bio-Oss Collagen® is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge;
- Filling of periodontal defects;
- Filling of defects after root resection, apicoectorny, and cystectomy;
- Filling of extraction sockets to enhance preservation of the alveolar ridge;
- Elevation of the maxillary sinus floor;
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- Filling of per-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Geistlich Bio-Oss® is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge;
- Filling of infrabony periodontal defects;
- Filling of defects after root resection, apicoectorny, and cystectorny;
- Filling of extraction sockets to enhance preservation of the alveolar ridge;
- Elevation of the maxillary sinus floor;
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR); and
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Geistlich Combi-Kit Collagen is a convenience kit containing one unit of Geistlich Bio-Oss Collagen® and one unit of Geistlich Bio-Gide®. The two devices are packaged in double blisters in one package and then sterilized by gamma irradiation.
Geistlich Bio-Oss Collagen® is a combination of purified spongiosa (cancellous) natural bone mineral granules and 10% collagen fibers in a block form and is sterilized by gamma irradiation. Geistlich Bio-Oss Collagen® is the same as its predicate device, Bio-Oss Collagen®.
Geistlich Bio-Gide® is a pure collagen membrane with a bilayer structure. The porous surface (facing the bone) allows the ingrowth of bone forming cells, and the dense surface (facing the soft tissue) prevents the ingrowth of fibrous connective tissue into the bone defect. The membrane is made of collagen without further cross-linking, and is sterilized by gamma irradiation. The size of the Geistlich Bio-Gide® bilayer membrane to be provided in the Geistlich Combi-Kit Collagen convenience kit is 16mm x 22 mm. With the exception of the size of the membrane packaged in the convenience kit, Geistlich Bio-Gide® is the same as its predicate device, Bio-Gide®.
Geistlich Bio-Oss® spongiosa (cancellous) granules and Geistlich Bio-Oss® Block are natural non-antigenic porous bone mineral matrices. They are produced by removal of all organic components from bovine bone. Due to their natural structure, Geistlich Bio-Oss® and Geistlich Bio-Oss® Block, are physically and chemically comparable to the mineralized matrix of human bone. Geistlich Bio-Oss® is the same as its predicate device, Bio-Oss®.
The provided text is a 510(k) summary for a medical device called Geistlich Combi-Kit Collagen, along with its individual components Geistlich Bio-Oss Collagen®, Geistlich Bio-Gide®, and Geistlich Bio-Oss®.
Based on the nature of this document, which is a premarket notification to the FDA for substantial equivalence, it does not contain information about acceptance criteria or a study proving device performance against such criteria in the way one would expect for a diagnostic or AI-powered device. This document focuses on demonstrating that the new device (or modified devices, or convenience kit) is substantially equivalent to previously cleared predicate devices.
The key points from the provided text are:
- Device: Geistlich Combi-Kit Collagen (a convenience kit containing Geistlich Bio-Oss Collagen® and Geistlich Bio-Gide®), and modifications to the Instructions for Use of Geistlich Bio-Oss Collagen®, Geistlich Bio-Gide®, and Geistlich Bio-Oss®.
- Purpose of Submission: To market a convenience kit and modify IFUs.
- Basis for Clearance: Substantial equivalence to predicate devices (Bio-Oss Collagen®, Bio-Gide®, Bio-Oss®).
- Technological Characteristics: The devices have the "same design, same chemical composition, and same materials" as their respective predicate devices. The only noted difference for Geistlich Bio-Gide® in the kit is a slight modification in dimensions (16mm x 22 mm), which the sponsor asserts "does not change the intended use."
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance. This information is not typically part of a 510(k) submission for devices seeking clearance based on substantial equivalence to existing devices that are already well-established in the market. The FDA's 510(k) pathway, especially for devices like these bone graft materials and membranes, relies heavily on demonstrating that the new device is as safe and effective as a legally marketed predicate, often through comparison of materials, design, and intended use rather than new clinical trials with performance metrics.
The document states that the devices are "substantially equivalent" to their predicates. This "substantial equivalence" is the regulatory acceptance criteria for 510(k) clearance, rather than specific performance metrics like sensitivity, specificity, etc., which would be relevant for diagnostic or AI devices. The "study" proving this is the detailed comparison of the new devices' characteristics to those of the predicate devices.
§ 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.