(143 days)
Dentis s-Clean s-Line Mini is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, screw 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.
Dentis s-Clean s-Line Mini is composed of Fixture and Abutments. s-Clean SO-SL Fixture Mini is a thread type implant made of Pure titanium according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal Hex. The subject implant body has a two screw-joint (structured with Upper and Lower screw joints) and a hex anti-rotation design connection. The two-screw-joint feature is for diverse screw connection with other abutment that has 1.6M screw or 2.0M Screw. The surface of fixture is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone). The system includes various abutments (Cover Screw, Healing Abutment, Sole Abutment, TiN Half Coating Sole Abutment, Couple Abutment, TiN Half Coating Couple Abutment, Angled Abutment, TiN Half Coating Angled Abutment, Abutment Screw, Temporary Abutment, MU Straight Abutment, MU Angled Abutment, MU Angled Abutment Screw) made from Pure titanium (ASTM F67), Ti-6Al-4V (ASTM F136), or PEEK material. Some abutments have Anodizing (Gold Color) or TiN-Coating surface treatments.
This document (K210080) describes the Dentis s-Clean s-Line Mini, an endosseous dental implant system, and its substantial equivalence to predicate devices, rather than an AI/ML-driven device requiring a study to prove meeting acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).
The acceptance criteria described in this document are related to the physical, chemical, and mechanical properties, as well as the sterility and biocompatibility of the dental implant components, and their substantial equivalence to already marketed devices. The "study" proving acceptance is a series of non-clinical tests and comparisons to predicate devices.
Therefore, I cannot provide a table with "acceptance criteria and reported device performance" as typically found for AI/ML diagnostic devices (e.g., sensitivity, specificity). Instead, I will describe the non-clinical tests and their outcomes as presented in the document to demonstrate the device meets its acceptance criteria for safety and effectiveness as a physical medical device.
1. Table of Acceptance Criteria (for a physical dental implant) and Reported Device Performance
Since this is a physical dental implant, the "acceptance criteria" are based on meeting established standards and demonstrating substantial equivalence to predicate devices in terms of material, design, performance, and biocompatibility.
| Acceptance Criteria Category | Specific Criteria (as implied by tests/comparisons) | Reported Device Performance / Method of Proof |
|---|---|---|
| Material Composition | Conformance to ASTM F67 (Pure titanium) and ASTM F136 (Ti-6Al-4V ELI) standards. | Subject device components (fixture, cover screw, healing abutment, temporary abutment) are fabricated from Pure titanium (ASTM F67). Other abutments are fabricated from Ti-6Al-4V ELI (ASTM F136). Temporary abutment also made of PEEK. This demonstrates material compatibility with predicates. |
| Biocompatibility | Meet ISO 10993 standards (e.g., cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, implantation). | Biocompatibility testing was performed on predicate devices (K153639, K171027, K150344, K171694) and was leveraged for the subject device because both products are manufactured with the same materials and manufacturing process. Results met ISO 10993 criteria. |
| Sterilization | Effective sterilization and maintenance of sterility. | Fixture sterilization validation (ISO 11137-1,2,3) leveraged from predicate K192688. End User Sterilization Validation Test Report on Abutments (ANSVAAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1) leveraged from predicate K11364. Fixtures provided sterilized; other abutments provided non-sterilized for end-user sterilization. |
| Shelf-Life | Maintain integrity and performance over specified shelf-life. | Shelf-Life Test on fixtures leveraged from predicate K153639 (ASTM F1980), as material, sterilization, packaging, and manufacturing are the same. |
| Bacterial Endotoxin | Meet endotoxin limits for medical devices. | Bacterial Endotoxin Test Report on fixtures leveraged from predicate K192688 (ANSVAAMI ST72:2011, USP , USP ). |
| Mechanical Performance (Fatigue) | Withstand cyclic loading without failure, demonstrating structural integrity comparable to or better than predicates. | Fatigue Testing under worst-case scenario (ISO 14801:2016) was performed on the subject device. A comparative fatigue test between single-screw and dual-screw joint implants showed that the device performance was substantially equivalent. |
| Surface Characteristics | Comparable surface treatment properties to predicates. | Fixture surface treated with SLA (Sandblasted with Large-grit and Acid-etching). Surface roughness, surface composition analysis, and SEM imaging were provided (compared to K153639) to demonstrate substantial equivalence. |
| Dimensional Tolerance | Dimensions within acceptable manufacturing tolerances. | Reported tolerance of dimension for fixtures and abutments is within ± 1% range. This is a manufacturing acceptance criterion rather than a test result. |
| Indications for Use | Aligned with predicate devices for safe and effective use. | Identical indications for use as the primary predicate device (K153639), including use in partially/fully edentulous mandibles/maxillae, support for single/multiple unit restorations (cemented, screw-retained, overdenture, fixed bridgework), one/two-stage surgical procedures, and delayed loading. |
| Design Characteristics | Overall design comparable and functionally equivalent to predicates. | Detailed comparison tables are provided for each component (fixture, cover screw, various abutments, screws) against multiple predicate/reference devices, highlighting similarities in design, diameter, length, angulation (where applicable), coating, and material. Any differences are explained and justified by comparison to other referenced devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document doesn't specify a "test set" in the context of an AI/ML diagnostic algorithm. For the physical device, fatigue testing per ISO 14801 would involve a specific number of samples, but the exact count is not provided. Other tests like biocompatibility, sterilization, and shelf-life are typically performed on a limited number of samples representative of the product. The document states a comparative fatigue test was conducted.
- Data Provenance: Not applicable in the context of AI/ML. The "data" here refers to the results of non-clinical bench testing and material characterization. The manufacturer is Dentis Co., Ltd. from South Korea. The testing was performed according to international standards (ISO, ASTM, USP) and FDA-recognized guidance. It's a "prospective" assessment in that the tests were done on the manufactured devices to demonstrate their properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This is not applicable for a physical medical device submission like this one. "Ground truth" in this context refers to established standards (e.g., ISO for fatigue, ASTM for materials, ISO/AAMI for sterilization), which are derived from broad expert consensus in relevant fields (engineering, microbiology, toxicology, dentistry).
4. Adjudication Method for the Test Set:
- Not applicable as this is not an AI/ML diagnostic study with human readers. Test results are compared against defined standard criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, this type of study is not relevant for a physical dental implant. MRMC studies are typically for evaluating the diagnostic performance of AI/ML systems, often with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm or AI component in this dental implant.
7. The Type of Ground Truth Used:
- The "ground truth" for proving the device's acceptance is based on:
- International Standards: Conformance to recognized standards such as ISO 14801 (fatigue), ISO 10993 series (biocompatibility), ISO 11137 series (sterilization), ASTM F67, F136, F1980 (materials, shelf-life), and AAMI/USP guidelines for bacterial endotoxins.
- Predicate Device Comparison: Substantial equivalence is established by demonstrating that the subject device has the "same intended use and fundamental scientific technology" as legally marketed predicate devices, and any differences "do not raise different questions of safety and effectiveness."
8. The Sample Size for the Training Set:
- Not applicable. There is no AI/ML training set for this physical device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no AI/ML training set.
§ 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.