(215 days)
The S-Plant Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function. The smaller S-Plant Dental Implants (03.4, 3.6, 3.8, 4.2, 4.7, 5.2 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability is achieved with appropriate occlusal loading. The larger S-Plant Dental Implants (Ø6.0, 7.0 mm) can be placed with a conventional two stage surgical process with an option for transmucosal healing and are indicated for the molar region with delayed loading.
Dual abutments are intended for use with a dental implant to prosthetic restorations such as crowns, bridges, or overdentures. Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration. Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete.
The S-Plant Dental Implant System is comprised of dental implants, superstructures, instruments for prosthetics and surgical instruments. The S-Plant Dental Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations.
The S-Plant Dental Implant System fixtures are made of commercial pure titanium, grade 4 (ASTM F67) which have a S.L.A (Sand blasted large grit acid etched) treated surface and supplied sterile (gamma radiation). These fixtures can be used one stage surgery method or two stage surgery method. And that are surgically inserted into the upper and/or lower jawbone. The fixtures replace tooth roots providing a stable foundation for restorations. Geometrically, the implant is screw tvpe. An abutment is connected to the implant through a tapered joint.
The Abutment made of Ti-6AL-4V ELI alloy (ASTM F136) is intended for use as an aid in single or multiple-unit prosthetic restorations. It consists of Healing Abutment, Dual Abutment, and Abutment Screws. All abutments are supplied non-sterile and autoclaved by the end user.
The Cover Screw made of Ti-6Al-4V ELI alloy (ASTM F136), is an essential component in dental implant procedures. This device safeguards the internal threads of dental implant fixtures during the healing phase, ensuring a sterile environment for successful osseointegration.
The provided text describes the regulatory clearance of the S-Plant Dental Implant System and its components (Fixture, Dual Abutment, Healing Abutment, Abutment Screw, Cover Screw) by demonstrating substantial equivalence to predicate and reference devices. The acceptance criteria and the study that proves the device meets these criteria are primarily based on non-clinical testing and comparison with existing, legally marketed devices.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the FDA's "substantial equivalence" framework, meaning the device must perform as safely and effectively as legally marketed predicate devices without raising new questions of safety or effectiveness. The reported device performance is demonstrated by comparing its design, materials, intended use, and technological characteristics to the predicate and reference devices, and by non-clinical testing that meets established industry standards.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Substantial Equivalence and Standards) | Reported Device Performance |
|---|---|---|
| Intended Use | The device's intended use should be substantially equivalent to that of predicate devices, aiming for functional and aesthetic rehabilitation through prosthetic attachment in the upper and lower jaw arches to restore chewing function. | Fixture: "The S-Plant Dental Implant System is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic attachment to restore a patient's chewing function." This is directly compared to and found to be substantially equivalent to the predicate device (DIO UF HSA Internal Sub-merged Implant System, K122519) and reference device (DIO UF(II) Narrow Implant System, K161987). |
| Abutments (Dual, Healing): "Dual abutments are intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures." "Healing abutments are used to make a natural soft tissue shape before setting up prosthetics and removing cover screw after osseointegration." These are found to be substantially equivalent to their respective reference devices. | ||
| Cover Screw: "Cover Screws are used to protect the internal portion of the implant, preventing soft tissue growth into the implant, facilitating provisional restorations when necessary, and enabling the transition to final restoration components once osseointegration is complete." This is found to be substantially equivalent to its reference device. | ||
| Abutment Screw: "Abutment Screw is used to connect an abutment to the fixture." This is found to be substantially equivalent to its reference device. | ||
| Materials | Device materials should be biocompatible and consistent with established standards for dental implants and their components (e.g., CP Ti Grade 4, Ti-6Al-4V ELI alloy). | Fixture: "commercial pure titanium, grade 4 (ASTM F67)". Compared to predicate/reference devices also using CP Ti Grade 4 (ASTM F67). |
| Abutment (Dual/Healing), Abutment Screw, Cover Screw: "Ti-6AL-4V ELI alloy (ASTM F136)". Compared to reference devices also using Titanium Alloy (Ti-6Al-4V, ASTM F136) or Pure Titanium Grade 4 (ASTM F67) for healing abutment. Demonstrated biocompatibility through ISO 7405, ISO 10993-1, -3, -5, -6, -10, -11, -12 testing. | ||
| Design and Dimensions | The device's design (e.g., screw type, tapered conical hex connection, surface treatment) and range of dimensions should be comparable to predicate devices. Minor variations should not raise new safety or effectiveness concerns. | Fixture: "Geometrically, the implant is screw type. An abutment is connected to the implant through a tapered joint." "S.L.A (Sand blasted large grit acid etched) treated surface." Dimensions are provided in a detailed table and compared to predicate/reference devices; "The S-Plant Dental Implant System also includes diameters (3.4mm and 3.6mm) that are not covered by the predicate device, but they fall within the range between the diameter of the reference device (K161987) and the diameter of the predicate device." Found substantially equivalent. |
| Abutments, Screws, Cover Screw: Designs are shown via images (text states "Image: Subject Device Design") and dimensions are provided/compared in tables, demonstrating substantial equivalence. For Abutment Screw, explicit mention that "Although the diameter and length of the screws differ slightly, the gap range is minimal, measuring less than 1-1.5mm. Consequently, this variance does not give rise to any concerns about the safety and effectiveness..." | ||
| Surface modification confirmed via EDS and SEM evaluations. | ||
| Sterilization | The device should be sterilized according to validated methods and have an appropriate shelf life. | Fixture: "supplied sterile (gamma radiation)." Sterilization validation included gamma radiation and gravity displacement moist heat, per ISO 11137-1, ISO 11137-2, ANSI/AAMI ST79. Shelf life of 8 years determined through accelerated aging studies, longer than predicate's 5 years, but not raising new safety concerns. Abutments are supplied non-sterile and autoclaved by the end user (as expected for these components). |
| Biocompatibility | The device must be biocompatible, demonstrating no unacceptable levels of toxicity, irritation, sensitization, or local effects after implantation. | Tested per ISO 7405, ISO 10993-1, ISO 10993-3 (genotoxicity, carcinogenicity, reproductive toxicity), ISO 10993-5 (cytotoxicity), ISO 10993-6 (local effects after implantation), ISO 10993-10 (irritation and skin sensitization), ISO 10993-11 (systemic toxicity), and ISO 10993-12 (sample preparation). All tests "met the criteria set by industry standards". |
| MRI Safety | The device should be safe for use in magnetic resonance (MR) environments, with appropriate labeling. | "Non-clinical worst-case MRI review was performed... using scientific rationale and published literature... based on the entire system... to include all variations... and material compositions." Rationale addressed parameters per FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. Implies that the device meets "MR Conditional" criteria. |
| Manufacturing Controls | The device manufacturer must adhere to Quality System (QS) regulations (21 CFR Part 820), including design controls and change management. (Implicit, as this is a general requirement for all devices). | The FDA letter mentions that the device is "subject to... the Quality System (QS) regulation (21 CFR Part 820), which includes... design controls; nonconforming product; and corrective and preventive action." This is an ongoing regulatory requirement for the manufacturer. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The information provided does not describe a clinical study with a test set of patient data. Instead, it details non-clinical testing (bench testing, biocompatibility testing, sterilization validation, shelf-life determination, and MRI safety assessment) and a comparative analysis of the device's characteristics against predicate and reference devices.
- Sample Size for Test Set: Not applicable in the context of patient data. The "test set" refers to samples of the device components used for various laboratory tests (e.g., material samples for biocompatibility, sterility test units, accelerated aging samples, MRI phantom testing). The specific number of samples for each non-clinical test is not detailed in this summary but would be found in the full submission.
- Data Provenance: The studies are non-clinical (laboratory/bench testing) and therefore do not involve patient data from specific countries or have a retrospective/prospective nature in the typical clinical sense. The tests were conducted by the manufacturer (IDIS Co., Ltd. in Republic of Korea) or their designated testing facilities to demonstrate compliance with international standards (ISO, ASTM, ANSI/AAMI) as required for FDA clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving expert readers interpreting medical images or clinical outcomes. Ground truth for non-clinical tests is established by adhering to defined scientific methodologies and international standards for material science, biomechanics, and biocompatibility.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication method described as this is not a study involving human interpretation of data for ground truth establishment.
5. 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. This submission does not involve an AI-enabled device or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This submission does not pertain to an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the substantial equivalence determination and non-clinical testing is based on:
- Established Industry Standards and Regulations: ISO 7405, ISO 10993 standards (biocompatibility), ISO 11137-1/2, ANSI/AAMI ST79 (sterilization), ASTM F1980 (shelf life), ASTM F67, ASTM F136 (materials), and FDA guidance documents (e.g., "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment").
- Predicate and Reference Device Specifications: The detailed characteristics (materials, dimensions, surface treatment, intended use) of the legally marketed predicate and reference devices serve as the benchmark for comparison to claim substantial equivalence.
8. The sample size for the training set
Not applicable. There is no training set mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as no training set is described.
§ 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.