(218 days)
The s-Clean OneQ-SL Narrow Implant System (3.0, 3.3mm) 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
- with a temporary prosthesis that is not in functional occlusion,
- when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
- 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 s-Clean OneQ-SL Narrow Implant System is used to replace missing teeth in various situations ranging from a single tooth loss to the complete loss of incisors teeth. This system is restricted to substitute the maxillary lateral incisors and mandibular incisors. It is one and two stage endosseous screw type implant with internal double hexagonal connection, intended for single use. The s-Clean OneQ-SL Narrow Implant System is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveola ridge.
This system consists of the fixture, cover screw, various abutments and prostheses. Only the subject abutments can be used with the subject fixtures.
This document describes the regulatory submission for the s-Clean OneQ-SL Narrow Implant System by Dentis Co., Ltd. The document is primarily a 510(k) summary demonstrating substantial equivalence to predicate devices, rather than a standalone study documenting acceptance criteria and performance. Therefore, detailed information on acceptance criteria and specific study results proving the device meets those criteria, particularly for clinical outcomes, is limited.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with quantified performance targets and corresponding device performance for direct comparison in the way a clinical study report would. Instead, it relies on non-clinical testing against recognized standards to demonstrate equivalence.
The "acceptance criteria" are implied by adherence to these standards and the demonstration of "substantial equivalence" to predicate devices. The "reported device performance" is essentially that the device met the criteria of these standards and demonstrated substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Absence of adverse biological reactions per ISO 10993 standards. | Met criteria of ISO 10993-1, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11. |
| Fatigue strength: Mechanical durability under cyclic loading per ISO 14801. | Met criteria of ISO 14801:2007. |
| Endotoxin levels: Within acceptable limits per USP . | Met criteria of USP . |
| Sterilization validation: Effective terminal sterilization (gamma) per ISO 11137. | Met criteria of ISO 11137-1, ISO 11137-2 (leveraged from predicate). |
| End-user steam sterilization: Effective sterilization for non-sterile components per ISO 17665-1,-2 and ANSI/AAMI ST79. | Met criteria of ISO 17665-1,-2 and ANSI/AAMI ST79 (leveraged from predicate). |
| Shelf life: Packaging integrity and product sterility maintained per ISO 11607 and ASTM F1980. | Met criteria of ISO 11607-1, ISO 11607-2, and ASTM F1980-07 (leveraged from predicate). |
| Surface characteristics: Equivalence to predicate devices. | Evaluated by Scanning Electron Microscopy and Energy Dispersive Spectroscopy, results demonstrated substantial equivalence. |
| Structural Integrity: Per applicable sections of "Guidance for Industry and Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments". | Met guidance document requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of human clinical data. All reported tests are non-clinical (biocompatibility, fatigue, endotoxin, sterilization, shelf life, surface characterization).
For non-clinical tests, sample sizes would typically be determined by the specific standards (e.g., ISO 14801 for fatigue testing might specify a minimum number of samples). The document states the tests were performed "for predicate devices and leveraged for the subject device" or "for the subject device." No specific sample numbers for these non-clinical tests are provided.
The "data provenance" for non-clinical tests is from the manufacturer's own testing (Dentis Co., Ltd.) or testing supporting their predicate devices. There is no mention of country of origin for non-clinical test data, but the manufacturer is based in South Korea.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a non-clinical submission demonstrating substantial equivalence through engineering and material testing, not human clinical trials requiring expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set
Not applicable for a non-clinical submission.
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 device is a dental implant system, not an AI-powered diagnostic or assistive technology for human readers. No MRMC study was performed or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (dental implant system), not an algorithm or software. Its performance is evaluated through material and mechanical testing, not algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" is established by the specifications and pass/fail criteria defined in the referenced international standards (e.g., ISO 10993, ISO 14801, USP ), and by demonstrating material/design equivalence to legally marketed predicate devices. There is no biological "ground truth" from pathology or outcomes data generated by this submission directly for the subject device.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this device.
§ 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.