(230 days)
MIS Dental Implant Systems are 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved, and the occlusal load is appropriate.
Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
The long MIS (18 & 20 mm) implants can be used in a tilted manner.
MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.
The subject MIS Dental Implant Systems are endosseous dental implant devices which are modified as subject to this premarket notification with a revised sterile packaging configuration. There are no modifications subject to this premarket notification which relate to the geometric or material composition design of the subject dental implant devices themselves. The individual product variants of the MIS Dental Implant Systems which are modified as subject to this premarket notification will be rebranded "MIS CLEAR". The subject implants are identical to the predicate and reference MIS implant systems in terms of their indications for use, design, constituent materials and manufacturing process. The subject MIS Dental Implants Systems only differ in their final packaging configuration, as subject to this premarket notification. The subject, predicate and reference MIS Dental Implants Systems are supplied in a double tube packaging configuration, wherein the outer tube serves as the sterile barrier, and the implant device is located within the inner tube. While the predicate and reference MIS Dental Implants Systems are supplied within a "dry" inner package tube, the subject devices as modified in this premarket notification are supplied in a modified inner tube containing liquid, in the form of NaCl solution. The liquid environment is intended to maintain the super-hydrophilic property (contact angle exhibited by water in contact with the surface is equal to zero degrees) of the subject MIS Dental Implants Systems, as subject to this premarket notification, until their use in patients. The outer tube serving as the sterile barrier is unchanged compared to the predicate and reference devices.
The provided context describes a 510(k) premarket notification for MIS Dental Implant Systems. The primary change being assessed is a modification to the inner packaging of the implants, specifically, the introduction of an NaCl solution to maintain the super-hydrophilic property of the implants.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of predetermined acceptance criteria. Instead, it describes various non-clinical tests performed and states that the data supports the desired outcome. The device's performance, as reported, is that it meets the requirements of these tests.
| Test Type | Reported Device Performance |
|---|---|
| Cytotoxicity | No toxic effects observed after one year accelerated shelf-life simulation. |
| Chemical Characterization | No foreign or unexpected materials present after one year accelerated shelf-life simulation. |
| Sterilization | Achieves sterility assurance level (SAL) of at least 10^-6^ in accordance with ISO 11137-1:2015 and ISO 11137-2:2015. |
| Transportation | Survives transportation conditions in accordance with ASTM 4332-14 and ASTM D 4169-16. |
| Hydrophilicity | Super-hydrophilic properties maintained after one year accelerated shelf-life. |
| Fatigue Testing | Mechanical endurance limit of implants is unaffected by NaCl environment (referenced from predicate device studies). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each non-clinical test mentioned (e.g., number of implants tested for cytotoxicity).
The data provenance is from non-clinical bench testing performed to support this premarket notification. The country of origin of the data is not specified, but the applicant, Dentsply Sirona, is based in York, Pennsylvania, USA, and MIS Implants Technologies Ltd. (a Dentsply Sirona company) is listed as the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable because the studies detailed are non-clinical (bench testing) rather than clinical studies involving human observers or expert interpretation. Therefore, there was no ground truth requiring expert consensus.
4. Adjudication Method for the Test Set
This section is not applicable as the studies are non-clinical bench tests and do not involve human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical data was included in this premarket notification to support the substantial equivalence..."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable as the device is a physical dental implant system, not an algorithm or AI software for which standalone performance would be assessed.
7. Type of Ground Truth Used
For the non-clinical performance data, the "ground truth" or reference criteria would be defined by the standards and methods used for each test:
- Cytotoxicity: Negative control or established biocompatibility standards.
- Chemical Characterization: Baseline material composition and absence of unexpected leachables.
- Sterilization: Sterility assurance level (SAL) of 10^-6^ as per ISO 11137-1:2015 and ISO 11137-2:2015.
- Transportation: No damage or compromise to packaging or device integrity after simulated transport, as per ASTM 4332-14 and ASTM D 4169-16.
- Hydrophilicity: Maintenance of super-hydrophilic properties (contact angle of water is zero degrees).
- Fatigue Testing: Mechanical endurance limits established by ISO 14801:2016 for dental implants (referenced from predicate devices).
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as above.
§ 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.