(94 days)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
S.I.N. Dental Implants with lengths of 18, 20, 22, or 24 mm be tilted up to 30°. When used in the mandible or maxilla with implants with lengths of 18, 20, 22, or 24 mm at an angulation of 30°, a minimum of four implants must be used and must be splinted. When placed in the maxilla with lengths of 18, 20, 22, or 24 mm at angulations between 0° and less than 30°, the S.I.N. Dental Implants are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
The purpose of this submission is to add components to the S.I.N. Dental Implant System, which includes components cleared previously in K211921, K200992, and K170392.
This submission includes dental implants Epikut S with a Morse taper (CM) abutment interface and an acid-etched endosseous surface, and Epikut S Plus implants with an endosseous surface produced by acidetching followed by application of a hydroxyapatite coating (HA™M). The implant design and endosseous surfaces are nearly identical to the Epikut Plus CM implants cleared in K211921, with the exception of the implant-abutment connection (subject device 16° Morse taper, K211921 11.5° Morse taper), the additional body/platform diameter (4.0 mm), and the longer lengths (18, 20, 22, and 24 mm).
All subject device dental implants are manufactured from unalloyed titanium conforming to ASTM F67. The acid etching procedure is applied to all subject device dental implants. The acid etching process in this submission is identical to the process used to manufacture the dental implants cleared in K211921, and the HA100 surface treatment is identical to that cleared in K211921.
This FDA 510(k) summary (K222231) describes a dental implant system and focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than on presenting a study with specific acceptance criteria, test sets, or performance metrics in the way these terms are typically used for AI/ML-based diagnostic devices.
The document is a regulatory submission for a medical device (S.I.N. Dental Implant System), not a study evaluating algorithm performance. Therefore, it does not contain information about:
- A table of acceptance criteria and reported device performance in the context of an algorithm's diagnostic accuracy.
- Sample sizes, data provenance, number of experts, adjudication methods for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Sample size for training sets or how ground truth for training sets was established.
Instead, the document focuses on non-clinical performance data to show that the new components of the S.I.N. Dental Implant System (subject device) are as safe and effective as existing legally marketed devices.
Here's an breakdown of the acceptance criteria (or rather, the demonstration of equivalence) and the studies (non-clinical tests and analyses) that prove the device meets these criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating that the subject device's design, materials, manufacturing, sterilization, and performance characteristics are substantially equivalent to predicate devices already cleared by the FDA. The performance data presented are non-clinical and relate to the physical and biological properties of the implant.
| Acceptance Criteria (Demonstrated Equivalence to Predicate Devices) | Reported Device Performance (as demonstrated by non-clinical studies/analysis) |
|---|---|
| Intended Use (Functional and esthetic rehabilitation of edentulous mandible or maxilla) | Equivalent to K211921, K203725, K170392, and K050406. The subject device's Indications for Use statement is largely identical or similar to the predicate devices, with specific language related to tilting angles and required number of implants/splinting justified by K050406 and K203725. |
| Material Composition (Unalloyed titanium, ASTM F67) | Equivalent to K211921, K203725, K170392. All subject device implants are manufactured from the same material. |
| Endosseous Surface Treatment (Acid-etched; HA™ for Epikut S Plus) | Equivalent to K211921 and K170392 for acid-etching. The HA™ treatment is identical to that cleared in K211921. Characterization (SEM, XPS, TEM, XRD, adherence) from K211921 leveraged. |
| Sterilization Method & Sterility Assurance Level (SAL) (Gamma irradiation to 10⁻⁶ SAL at 25 kGy) | Equivalent to K211921 and K203725. Sterilization method selected and substantiated according to ISO 11137-1 and ISO 11137-2. |
| Bacterial Endotoxin Limit ( |
§ 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.