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The ZENEX Implant System Narrow (3.0, 3.2mm) may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.

The implants may be restored immediately

1. with a temporary prosthesis that is not in functional occlusion,
2. when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
3. for denture stabilization using multiple implants in the anterior mandible and maxilla.
   The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.

The ZENEX Implant System Narrow consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The fixtures and abutments in this system are: ZENEX MULTI Fixture, ZENEX PLUS Fixture, Cover Screw, Healing Abutment, Cemented Abutment (Hex, Non-Hex), Angled Abutment (Hex, Non-Hex), Temporary Abutment (Hex, Non-Hex), FreeMilling Abutment (Hex, Non-Hex), CCM Cast Abutment (Hex, Non-Hex), and Abutment Screw. An endosseous dental implant is a device made of a material such as Ti 6AL 4V Eli (Conforming to ASTM Standard F-136). The implant-Abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the ZENEX MULTI and PLUS Fixtures are treated with SLA(sand-blasted, large-grit, acid-etched). The subject fixture, cover screw and healing abutment are provided sterile. Other abutments are provided non-sterile and packaged separately.

The provided text is a 510(k) summary for the ZENEX Implant System Narrow, a dental implant device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and performance studies for an AI/ML device cannot be extracted from this document.

The document details:

• Device Description: Components (fixtures, abutments), materials (Ti-6Al-4V ELI, Co-Cr-Mo Alloy), and surface treatments (SLA, TiN coated).
• Indications for Use: Single tooth replacement, multiple tooth replacement, denture stabilization.
• Predicate Devices: A list of previously cleared dental implants and accessories used for comparison.
• Substantial Equivalence Discussion: A comparative table outlining various characteristics of the subject device against its primary predicate and reference devices, focusing on design, connection, material, surface, sterilization, shelf life, and indications for use.
• Non-Clinical Data: Lists mechanical and material tests conducted (Bacterial Endotoxin, Fatigue Testing on fixture) and leveraged from predicate devices (Sterilization Validation, Shelf-Life, End User Sterilization Validation, Biocompatibility). It also mentions an MR environment review.

There is no information in this document about:

1. Acceptance criteria for an AI/ML device.
2. Reported device performance metrics (e.g., sensitivity, specificity, accuracy) of an AI/ML device.
3. Sample sizes for test sets in an AI/ML study.
4. Data provenance for an AI/ML study.
5. Number or qualifications of experts for AI/ML ground truth.
6. Adjudication methods for AI/ML ground truth.
7. MRMC comparative effectiveness study results for AI/ML.
8. Standalone performance of an AI/ML algorithm.
9. Type of ground truth used for an AI/ML study.
10. Sample size for the training set of an AI/ML model.
11. How ground truth for the training set was established for an AI/ML model.

This 510(k) summary is for a physical dental implant system, not a software or AI/ML-driven device.

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