(90 days)
Dentis s-Clean s-Line 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 is composed of Fixture and Abutments. s-Clean SQ-SL Fixture 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 surface of fixture is treated with SLA (Sandblasted with Large-grit and Acidetching). The device includes various abutments made from Ti-6A1-4V (ASTM F136) and Chrome-cobalt-molybdenum (CCM) alloy material (ASTM F1537). Some abutments have a TiN coating. Some components are provided sterile, while others are non-sterilized.
The provided text describes a 510(k) premarket notification for a dental implant system (Dentis s-Clean s-Line). This document primarily focuses on establishing substantial equivalence to previously cleared predicate devices. Therefore, it does not present a typical device performance study with specific acceptance criteria and reported numerical performance metrics.
Instead, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to predicate devices through various tests and comparisons, particularly in terms of:
- Indications for Use
- Design and dimensions
- Materials
- Surface treatments
- Sterilization methods
- Biocompatibility
- Dynamic fatigue and static strength
The "study that proves the device meets the acceptance criteria" is fundamentally the comparative analysis against the predicate and reference devices, along with performance testing (dynamic fatigue, static strength) and biological assessment (biocompatibility).
Here's an attempt to structure the information based on your request, acknowledging that the format of a 510(k) summary is different from a clinical study report.
Implied Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to legally marketed predicate devices. The performance data presented is in comparison to these predicates rather than against pre-defined numerical thresholds for novel performance.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicates) | Reported Device Performance (as demonstrated by comparison/testing) |
|---|---|
| Mechanical Performance: |
- Dynamic Fatigue Strength
- Static Strength | Tests conducted according to FDA guidance and ISO 14801:2016 for worst-case scenario. Results are implied to be equivalent to predicate (as no significant differences were cited to impact performance). |
| Material Characteristics: - Adherence to ASTM standards (F67, F136, F1537)
- Surface characteristics (SLA, TiN coating) | Fixtures made of CP Titanium Gr4 (ASTM F67). Abutments from Ti-6Al-4V (ASTM F136) and Chrome-cobalt-molybdenum (ASTM F1537).
SLA surface identical to K153639. TiN coating identical to K171694. EDX, SEM, surface roughness, coating thickness, porosity, adhesion leveraged from predicates. |
| Biocompatibility: - Non-cytotoxic, non-sensitizing, non-irritating | Biological assessment performed according to ISO 10993-1:2009 and FDA Guidance. Device has equivalent nature of body contact, duration, material formulation, and sterilization methods compared to predicates, thus no new issues raised. |
| Sterilization: - Sterility Assurance Level (SAL) of 10^-6
- Shelf Life Validation
- Pyrogenicity | Validated in accordance with ISO 11137-1:2006.
Shelf life of 8 years for sterile devices, validated per ASTM F1980.
LAL Endotoxin Analysis (testing limit 20 EU/device) meets pyrogen limit specifications. |
| Dimensional Tolerance: - Fixtures and Abutments | Stated tolerance of
± 1% rangefor dimensions. The dimensions of the subject device are stated to be "in range" or "similar" to the predicate devices and not to impact device performance. |
Detailed Information as Requested:
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A table of acceptance criteria and the reported device performance: (See table above).
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify a "test set" in the context of a clinical study or human subject data. The samples for mechanical testing (dynamic fatigue, static strength) and biocompatibility are laboratory samples/implants, not patient data.
- The document does not provide details on the number of samples used for these specific tests.
- Data Provenance: The mechanical and surface characteristic data were leveraged from previous clearances (K153639, K171694, K082843, K150344, K171027), indicating prior existing test results. It is prospective testing for the elements that are different or new, but retrospective use of data for elements deemed identical to predicates. Country of origin for testing is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This question is not applicable to a 510(k) submission based on mechanical and biocompatibility testing. There is no "ground truth" established by experts in the clinical sense for this type of submission. The "ground truth" for material properties and mechanical performance would be the universally accepted standards (ASTM, ISO) and the empirical results of the tests themselves, interpreted by qualified engineers/scientists.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication method is used in clinical trials or diagnostic accuracy studies involving expert panel reviews, which are not part of this 510(k) submission for mechanical equivalence.
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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. This pertains to AI/CAD devices, not dental implants. No MRMC study was conducted or relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This pertains to AI/CAD devices, not dental implants.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical and material aspects, the "ground truth" is defined by international standards (ISO, ASTM) and regulatory guidance (FDA Guidance Documents) for dental implants. The device components are compared against these established specifications and the validated characteristics of the predicate devices.
- For biocompatibility, the ground truth is established by recognized biological evaluation standards (ISO 10993-1).
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The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm that requires a 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.