(94 days)
This device 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, and to restore the patient's chewing function. It may be used for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading.
This device is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
These devices are intended for intra-bony and inter-radicular transitional applications, to permit immediate splinting stability and ongoing fixation of new or existing crown and bridge installations for full or partial edentualism such as: Support anchors for temporary restorations during the healing and osseointegration process of permanent implants. Immediate loading temporary abutments for repairing failing tooth and implant supported restorations. Transitional supports for immediate replacement of missing teeth, For use in front maxilla where 4 or more implants are splinted together, may be loaded immediately.
This device is an endosseous dental implant consisting of the major component, a root-form, screw type, self-tapping implant, and accessories, designed to facilitate placing and using the implant in various procedures. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are of course subject to general controls and are covered by the Quality System documents. The head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The heads of this implant are provided in several shapes to meet several needs described in the indications section, including round, square, and cylindrical. The JJG Evolution™ implant is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.
This device is an endosseous dental implant consisting of the major component, a root-form, screw type implant with a specialized head, and accessories, designed to facilitate placing and using the implant in orthodontic procedures.. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are described in Quality System documentation.. The smoothly curved head has a groove in the middle for the attachment of elastics, chains, or coil springs commonly used in orthodontics. The head has a 0.7 mm aperture where a wire or auxiliary can be attached. The rounded head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The JJG Evolution™ Orthodontic implant is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.
This device is an endosseous dental implant consisting of the major component, a root-form, screw type, self-tapping implant, and accessories, designed to facilitate placing and using the implant. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally but are of course subject to general controls and are covered by the Quality System documents. The head of the implant has an internal square for insertion of the screw driver. The body has a cylindrical shape with tapered point with self tapping threads. The heads of this implant are provided in several shapes to meet several needs described in the indications section, including round, square, and cylindrical. The JJG Evolution™ Monoblock Implant system is made of titanium or titanium alloy, both of which meet FDA recognized consensus standards.
The provided text is a 510(k) summary for the J.J.G. Evolution™ Mini-Implant System, Orthodontic Implant System, and Monoblock Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.
Therefore, many of the requested sections about specific study details (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication method, MRMC study, standalone performance, ground truth type and establishment) cannot be extracted from the provided document as this type of information is generally not part of a 510(k) summary for devices demonstrating substantial equivalence based on material and design similarity.
The document states: "No performance standards are applicable, however we followed 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments' issued May 12, 2004." This indicates that compliance is primarily based on meeting material specifications and functional similarity to predicates, rather than proving specific performance metrics through a clinical study.
Here's a summary of what can be extracted:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are primarily based on substantial equivalence to legally marketed predicate devices, as defined by the FDA's "510(k) 'Substantial Equivalence' Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3." This means the devices must have the same intended use and similar technological characteristics (materials, design, manufacturing concepts) as their predicates.
The study presented is essentially a comparison to predicate devices rather than a performance study against numerical acceptance criteria.
| Acceptance Criteria (based on Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same Intended Use (for each system): | Met: |
| - Mini-Implant System: For intra-bony and inter-radicular transitional applications including support anchors for temporary restorations, immediate loading temporary abutments, transitional supports for immediate replacement of missing teeth, and immediate loading in front maxilla where 4+ implants are splinted. | "These products have the same intended use as predicate devices..." (e.g., Dentatus MTI, Sendax MDI) |
| - Orthodontic Implant System: To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth, used temporarily and removed after treatment. | "These products have the same intended use as predicate devices, intended to provide a fixed anchorage point for attachment of orthodontic appliances..." (e.g., Alpha-Bio Tec, Dentaurum, Straumann Ortho implant) |
| - Monoblock Implant System: To replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained, intended for immediate implantation in extraction sites and immediate loading. | "These products have the same intended use as predicate devices..." (e.g., Zimmer One Piece Implant, Astra Tech, Nobel Biocare) |
| Similar Technological Characteristics (for each system): | Met: |
| - Material Composition: Titanium or titanium alloy (CP titanium meeting ASTM F-67, titanium alloy meeting ASTM F-136). | "manufactured from either titanium or titanium alloy." (Mini-Implant report) |
| "made of titanium or titanium alloy, both of which meet FDA recognized consensus standards." (Orthodontic and Monoblock reports) | |
| "The materials (titanium and titanium alloy) are identical to some of the implants, and similar to those of the others made of titanium alloy." | |
| - Design and Manufacturing Concepts: Screw-type, self-tapping, root-form, one-piece implants with various head shapes and dimensions (e.g., 1.5 to 2.8mm diameter, 10 to 20mm length for Mini-Implants). Specific features like grooves for elastics on Orthodontic implants, or roughened root form and smooth neck for Monoblock implants. | "They are screw-type, self-tapping endosseous dental implants with design and manufacturing concepts and materials similar to those of the predicate devices." (Mini-Implant report) |
| "Like the Jeil Medical Dual Top system, they have a rounded head with a groove around it for the attachment of elastics, chains or coil springs." (Orthodontic report) | |
| "Like several of the predicate devices, the J.J.G. Evolution™ Monoblock Implants are post-type, tapered form, with spirals... manufactured with the root form treated to roughen it or otherwise hasten osseointegration, a smooth 'neck' to hasten tissue attachment..." (Monoblock report) | |
| Compliance with Consensus Standards/Guidance: | Met: Compliance with "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ASTM F-67 / F-136. |
Study Details
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Sample size used for the test set and the data provenance:
- Not applicable/Not provided. The submission is based on a comparison of device characteristics and intended use to existing predicate devices, not a clinical trial or performance study with a test set of data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Ground truth in the context of a dataset is not relevant for this type of substantial equivalence submission.
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Adjudication method for the test set:
- Not applicable/Not provided.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable/Not provided. This is not a study involving human readers or AI.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This is not an algorithm-based device.
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The type of ground truth used:
- Not applicable/Not provided. The "ground truth" here is regulatory compliance and functional similarity to established predicate devices, rather than a clinical outcome or diagnostic truth.
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The sample size for the training set:
- Not applicable/Not provided. There is no training set mentioned, as this is not a machine learning or statistical model.
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How the ground truth for the training set was established:
- Not applicable/Not provided.
§ 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.