(116 days)
The MS SA Implant (Denture) is intended to be placed in the bone of the upper or lower jaw arches to provide support of the prosthetic devices to restore the patient's chewing function, including the denture stabilization. The MS SA Implant (Denture) is intended for single use only. It is intended for delayed loading.
The MS SA Implant (Narrow Ridge) is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The MS SA Implant (Narrow Ridge) is intended for single use only. It is intended for delayed loading.
The MS SA Implant System is a dental implant made of titanium alloy (Ti-6Al-4V) metal. The MS SA Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface treatment of MS SA Implant System is SA (Sandblasting and Acid etching).
The provided text describes a 510(k) premarket notification for the "MS SA Implant System," a dental implant device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical efficacy through new clinical trials against acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, specific study designs (like MRMC), and detailed performance metrics derived from such studies is not available in this document.
Here's what can be extracted and inferred from the text:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is assessed by comparing the device's characteristics to those of the predicate devices. The table below summarizes the comparison presented in the document.
| Feature | MS SA Implant System (Narrow Ridge) | MS System (Narrow Ridge) (Predicate) | Straumann Dental Implants (Predicate) (for surface) |
|---|---|---|---|
| Intended Use | Treatment of missing mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, to restore chewing function in partially edentulous patients. Single use only. Delayed loading. | Treatment of missing mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, to restore chewing function in partially edentulous patients. Single use only. | Immediate placement and function for single and/or multiple tooth applications with good primary stability and appropriate occlusal loading to restore chewing function. Multiple tooth applications may be rigidly splinted. For edentulous patients, four or more implants must be used. Supports prosthetic restorations in edentulous or partially edentulous patients. Maxillary and/or mandibular arches. |
| Structure | SA(Sandblasting and Acid etching). Threaded Body Design. One Body Implant. | R.B.M (Resorbable Blasting Media). Micro Thread Design. Threaded Body Design. One Body Implant. | Single Thread. Straight body Type. Non-submerged fixture. |
| Thread Body Dia | 2.5, 2.9 (mm) | 2.5, 3.0 (mm) | 3.3~4.8 (mm) |
| Length of Thread | 8.5, 10.0, 11.5, 13.0 (mm) | 8.5, 10.0, 11.5, 13.0, 15.0 (mm) | 6.0~16.0 (mm) |
| Material | Titanium alloy Ti-6Al-4V (ASTM F 136) | Titanium alloy Ti-6Al-4V (ASTM F 136) | Pure Titanium Grade 4 (ASTM F67) |
| Surface | SA (Sandblasting and Acid etching) | R.B.M (Resorbable Blasting Media) | SLA (Grit blasting, acid etched SLA surface) |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Substantial Equivalence Statement | Same material, indication for use, and similar design as MS System (K083067), except for surface treatment. Surface treatment is similar to Straumann Dental Implants (K061176). | (Reference for comparison) | (Reference for comparison) |
| Feature | MS SA Implant System (Denture) | MS System (Denture) (Predicate) | Straumann Dental Implants (Predicate) (for surface) |
|---|---|---|---|
| Intended Use | Placed in the bone of the upper or lower jaw arches to provide support of prosthetic devices to restore chewing function, including denture stabilization. Single use only. | Placed in the bone of the upper or lower jaw arches to provide support of prosthetic devices to restore chewing function, including denture stabilization. Single use only. | Immediate placement and function for single and/or multiple tooth applications with good primary stability and appropriate occlusal loading to restore chewing function. Multiple tooth applications may be rigidly splinted. For edentulous patients, four or more implants must be used. Supports prosthetic restorations in edentulous or partially edentulous patients. Maxillary and/or mandibular arches. Narrow Neck implants indicated for replacement of single lateral incisors in maxilla and lateral/central incisors in mandibles, for limited interdental and vestibule-oral bone space. Can support full arch implant-born restoration with a standard Straumann 4.1 mm dental implant. |
| Structure | SA(Sandblasting and Acid etching). Ball-shaped suits for O-Ring attachment. 2/4mm can be used according to gingival height. Threaded Body Design. | R.B.M (Resorbable Blasting Media). Ball-shaped suits for O-Ring attachment. 2/4mm can be used according to gingival height. Micro Thread Design. Threaded Body Design. | Single Thread. Straight body Type. Non-submerged fixture. |
| Thread Body Dia | 2.5, 2.9 (mm) | 2.0, 2.5, 3.0 (mm) | 3.3~4.8 (mm) |
| Length of Thread | 8.5, 10.0, 11.5, 13.0 (mm) | 8.5, 11.5 (mm) | 6.0~16.0 (mm) |
| Material | Titanium alloy Ti-6Al-4V (ASTM F 136) | Titanium alloy Ti-6Al-4V (ASTM F 136) | Pure Titanium Grade 4 (ASTM F67) |
| Surface | SA (Sandblasting and Acid etching) | R.B.M (Resorbable Blasting Media) | SLA (Grit blasting, acid etched SLA surface) |
| Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile |
| Substantial Equivalence Statement | Same material, indication for use, and similar design as MS System (K083067), except for surface treatment. Surface treatment is similar to Straumann Dental Implants (K061176). | (Reference for comparison) | (Reference for comparison) |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The submission states "No clinical studies are submitted." The evaluation relies on comparison to predicate devices and nonclinical testing.
- Data provenance: For mechanical testing ("Fatigue testing"), it is conducted according to "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment." This implies a standardized laboratory test, not patient data.
3. 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):
- Not applicable. No clinical test set requiring expert ground truth assessment was submitted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication was submitted.
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-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For the comparative evaluation, the "ground truth" is established by the documented characteristics, materials, and intended uses of the legally marketed predicate devices. For nonclinical testing (fatigue), the ground truth is adherence to established engineering standards and performance requirements for dental implants.
8. The sample size for the training set:
- Not applicable. No machine learning or AI component requiring a training set is involved.
9. How the ground truth for the training set was established:
- Not applicable. No machine learning or AI component requiring a training set is involved.
§ 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.