(72 days)
The Thommen SPI® CONTACT Dental Implant is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® CONTACT implants can provide support for immediate loading if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
Contraindications for the use of SPI® CONTACT implant ø 3.5 mm: These Implants are not suitable for applications in areas where pronounced rotation and translation movements occur, causing the implant to be subjected to large bending moments.
- Restoration of posterior teeth in the upper or lower jaw
- Single-tooth restoration of canines and central incisors in the upper jaw
- Any application involving retentive anchors.
Thommen SPI® CONTACT Dental Implants are threaded, tapered, endosseous dental implants made of commercially pure titanium and intended for use with the System abutments and instruments. The implants are offered in lengths ranging from 9.5 mm to 17 mm, with diameters from 3.5 mm to 6 mm.
This document is a 510(k) summary for a dental implant, and as such, it does not contain the level of detail typically found in a clinical study report. Specifically, it focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting detailed acceptance criteria and performance data from a dedicated study.
Therefore, many of the requested sections below cannot be fully answered or are marked as "Not Applicable (N/A)" because the information is not present in the provided text.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (from K034014) |
|---|---|---|
| Intended Use | "Surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures." | "The Thommen SPI® CONTACT Dental Implant is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures." (Met by identical statement) |
| Material Composition | Pure titanium according to ASTM F 67 Grade 4 / ISO 5832-2 GR4B | "SPI® CONTACT Dental Implants are made of pure titanium according to ASTM F 67 Grade 4/ ISO 5832-2 GR4B." (Met by identical statement) |
| Surface Treatment | Sandblasted and acid etched threaded portion; smooth machined collar (1.5mm) | "The surface of the threaded portion of the SPI® CONTACT implant is sandblasted and acid etched. The 1.5 mm collar is smooth machined for subgingival and transgingival use." (Met by identical statement) |
| Sterilization | Radiation sterilization via Co60 gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad); Sterility Assurance Level (SAL) of 10^-6; Validated by bioburden method according to ISO 11137. | "Thommen SPI® CONTACT Dental Implants will be packaged in a radiation resistant packaging. Sterilization will be accomplished by means of Co60 gamma irradiation at a nominal dose of 25 kGy (2.5 Mrad). Sterilization will be validated by the bioburden method, according to ISO 11137... The sterility assurance level (SAL) that we meet for the SPI® CONTACT Dental Implant is 10^-6." (Met by identical statements) |
| Substantial Equivalence (Overall Acceptance) | Demonstrate equivalence in intended use, operating principle, basic design, materials, packaging, and sterilization to predicate devices. | The FDA reviewed the 510(k) and "determined the device is substantially equivalent" to the predicate devices listed (K003045, K022038, K030689, K030007, K964220, K022562) based on these similarities. (Met by FDA determination) |
| Contraindications | Maintain specific contraindications for Ø 3.5 mm implants, including specific locations (posterior teeth, upper jaw canines/incisors) and applications (retentive anchors, pronounced rotation/translation movements). | The document explicitly lists the same contraindications. (Met by identical statements) |
| Design Characteristics (Dimensions) | Lengths ranging from 9.5 mm to 17 mm, with diameters from 3.5 mm to 6 mm. | "The implants are offered in lengths ranging from 9.5 mm to 17 mm, with diameters from 3.5 mm to 6 mm." (Met by identical statement) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not Applicable (N/A). This 510(k) relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study with a specific test set of patients or cases. The "test set" here refers to the comparisons made against the predicate devices' characteristics.
- Data Provenance: N/A. The data provided is primarily descriptive of the new device and comparative to existing predicate devices' established characteristics. There isn't a "data provenance" in the sense of a clinical trial's patient data origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not Applicable (N/A). No independent experts were used to establish ground truth for a test set as this is a 510(k) application for substantial equivalence based on product design and materials, not a clinical efficacy trial. The "experts" involved are the FDA reviewers who assessed the application.
- Qualifications of Experts: Not Applicable (N/A). See above.
4. Adjudication method for the test set
- Adjudication Method: Not Applicable (N/A). There was no test set requiring multi-expert adjudication. The FDA's review process resulted in a determination of substantial equivalence.
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
- MRMC Study: Not Applicable (N/A). This is a dental implant, not an AI or imaging device, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not Applicable (N/A). This is a physical medical device (dental implant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for this 510(k) submission is the established equivalency to predicate devices that have already met regulatory requirements and demonstrated safety and effectiveness through their own respective approval processes. This "ground truth" is based on:
- Regulatory Standards: Conformance to ASTM F 67 Grade 4 and ISO 5832-2 GR4B for materials, and ISO 11137 for sterilization.
- Predicate Device Characteristics: The detailed specifications (intended use, operating principle, basic design, materials, packaging, sterilization) of the legally marketed predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not Applicable (N/A). No "training set" is relevant for this type of device submission. The device's design and manufacturing parameters are based on established engineering principles and material science, not machine learning.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not Applicable (N/A). See 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.