(94 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
Neodent Implant System implants included in this submission are threaded, self tapping, root form, endosseous dental implants with an external hex abutment interface. They are made of commercially pure titanium, with a surface that is grit blasted and acid etched. Implants are provided in both a straight, double thread design and a tapered, single thread design. In addition, multiple straight abutments are provided for each diameter implant for both cement retained and screw retained prostheses.
This document (K101207) is a 510(k) premarket notification for the Neodent Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness are not present in the provided text.
Here is what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific performance acceptance criteria or quantitative performance metrics (e.g., accuracy, sensitivity, specificity) for the device itself are provided in this regulatory submission. The submission's focus is on demonstrating substantial equivalence to predicate devices in terms of intended use, operating principle, basic design, materials, packaging, and sterilization. Therefore, performance is implicitly accepted if substantial equivalence is demonstrated.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified directly in this type of submission for this device. | Not specified directly; performance is inferred through substantial equivalence to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. This is a 510(k) submission for a dental implant system, not a software device or diagnostic tool that would typically have a "test set" in the context of performance evaluation with accuracy metrics. The equivalence demonstration is based on design principles, materials, and intended use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable for this type of device and submission.
4. Adjudication Method for the Test Set:
Not applicable for this type of device and submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic or screening tools, particularly AI-driven ones where human reader performance is a key metric. This submission is for a physical medical device (dental implants).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical dental implant system, not an algorithm or AI-driven diagnostic tool.
7. The Type of Ground Truth Used:
Not applicable. For a physical device like a dental implant, "ground truth" would typically relate to mechanical properties, biocompatibility, and clinical outcomes. The submission focuses on demonstrating that the device's design, materials, and intended use are substantially equivalent to existing cleared devices, implying acceptable safety and effectiveness.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires training data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of available information from the document:
This 510(k) submission (K101207) for the Neodent Implant System focuses on demonstrating substantial equivalence to predicate devices already cleared by the FDA. The core of the "study" is a comparison of the Neodent Implant System to a list of predicate devices, asserting that it shares the same intended use, operating principles, basic design, materials, packaging, and sterilization methods.
- Device Description: Threaded, self-tapping, root-form, endosseous dental implants made of commercially pure titanium with a grit-blasted and acid-etched surface. Available in straight (double thread) and tapered (single thread) designs. Multiple abutments are provided.
- Intended Use: Surgically placed in the upper or lower jaw bone to support prosthetic devices (artificial teeth) to restore chewing function. Can be used with single-stage or two-stage procedures, for single or multiple unit restorations, and can be immediately loaded under specific conditions.
- Predicate Devices:
- Lifecore Biomedical Dental Implant Systems (K002037)
- Nobel Biocare NOBELSPEEDY™ Implants (K050406)
- Straumann ITT® Dental Implant System (K033922)
- Straumann synOcta® Prosthetics (K041295)
- Straumann UCLA Gold Abutment (K022859)
- Astra Tech Fixture MicroThread™ OsseoSpeed™ (K053384)
- Thommen Medical SPI® ART Abutment (K073141)
- Equivalence Claim: The Neodent Implant System has the same intended use, operating principle, basic design, same or very similar materials (commercially pure titanium conforming to ASTM F67 for implants; titanium alloy, gold alloy, zirconia for abutments), and similar packaging/sterilization methods as the predicate devices. Physical dimensions are also within the same range.
In essence, no specific study in the biomedical research sense (e.g., a clinical trial with performance metrics) is detailed for this 510(k). The "proof" is the argument for substantial equivalence based on comparing technical characteristics and intended use to already approved devices. The FDA's clearance of the 510(k) indicates their agreement with this substantial equivalence.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.