(29 days)
s-Clean SQ-SL Implant System Regular is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single- or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one- and two-stage surgical procedures. This system is intended for delayed loading.
This submission is to add new implants to the previously cleared device, s-Clean SQ-SL Implant System Regular (K192688). The newly added implant is "s-Clean SQ-SL Fixture with Ø5.2mm diameter".
The s-Clean SQ-SL Implant System Regular is composed of a fixture and cover screw. The s-Clean SQ-SL Fixture is a thread-type implant made of Commercial Pure Titanium Grade 4 according to ASTM F67 which is placed in the alveolar bone to replace the function of the missing tooth. This device has a connection between the upper prosthesis and the internal Hex.
The Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is the only part to be implanted into bone, to provide connection of prosthetic devices or other components of a dental implant set within the human body (mandibular or maxillary bone).
The document details a 510(k) premarket notification for the "s-Clean SQ-SL Implant System Regular" and relies on substantial equivalence to a predicate device (K192688) rather than presenting new clinical study data with acceptance criteria that would typically be associated with AI/ML device performance.
Therefore, the requested information elements related to AI/ML device performance, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth, and training set details, are not applicable to this submission.
The acceptance criteria provided in the document pertain to the physical and material characteristics, manufacturing processes, and sterilization validation of the dental implant, demonstrating its equivalence to the predicate device.
Here's the information that can be extracted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Reported Device Performance (Leveraged from Predicate) |
|---|---|
| Sterilization Validation | Met criteria of ISO 11137-1, 2, 3 |
| Shelf Life | Met criteria of ASTM F1980 |
| Biocompatibility | Met criteria of ISO 10993-1, 3, 5, 6, 10, 11 |
| Bacterial Endotoxin Test | Met criteria of ANSI/AAMI ST72, USP , USP |
| Surface Modification | Substantially equivalent (SLA treated) |
| Material | CP Titanium Gr. 4 (ASTM F67 compliant) |
| Indications for Use | Same as predicate device (K192688) |
| Diameters | Within range of predicate device diameters |
| Lengths | Same as predicate device (K192688) |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The submission leverages non-clinical test data from predicate devices (K192688 and K153639). No new clinical test set was used for the subject device to establish new performance metrics. The data provenance is implied to be from internal testing conducted by Dentis Co., Ltd. for the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No new clinical test set requiring expert ground truth was performed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No new clinical test set requiring adjudication was performed for this 510(k) 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, not an AI/ML diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a dental implant, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" here refers to the compliance with established international and national standards (e.g., ISO, ASTM, ANSI/AAMI, USP) for medical device materials, manufacturing, and sterilization, as demonstrated by the predicate devices.
8. The sample size for the training set:
- Not Applicable. This device is a dental implant, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. This device is a dental implant, not an AI/ML 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.