(21 days)
The Thommen SPI " ELEMENT Dental Implant is intended to be surgically placed in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® ELEMENT implant Ø 3.5 mm should be employed only at locations where the available bone structure (minimum width of alveolar ridge: 5-6 mm) precludes the use of a larger diameter. Blocking of multiple SP1 ELEMENT implants Ø 3.5 mm is recommended whenever possible. 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 movements (e.g. use of single implants for the restoration of canines).
Partially edentulous lower and upper jaw:
SPI® ELEMENT implants Ø 3.5 mm are suitable for alloplastic replacement of the lateral incisors (12, 22 = FDI System) in the upper jaw and the central and lateral incisors (41, 31, 42 and 32 = FDI System) in the lower jaw.
Edentulous lower jaw:
4 SPI® ELEMENT implant Ø 3.5 mm connected with a bar
Edentulous lower and upper jaw:
Complete bridges in combination with Ø 4.2 mm, 5.0 mm or 6.0 mm SP1® implants
The previously cleared SP® ELEMENT Dental Implant K003045 is not a subject of this Special 510(k). The design of this implant has been modified to make a smaller diameter (3.5 mm) implant that will be marketed as the SPP ELEMENT Dental Implant Ø 3.5 mm. Other SPY ELEMENT Dental Implant System accessories have not been modified, are suitable for use with the modified implant, and will be sold under the SPP Dental Implant System name.
The Thommen SPI® ELEMENT Dental Implant is a two-stage root formendosseous dental implant made of commercially pure grade titanium. The implant surface is smooth machined on the transgingival portion and sandblasted and acid-etched in the area designed to contact bone. The implant is offered in four lengths (8 mm, 11 mm, 14 mm, 17 mm) with one new diameter (3.5 mm) for each length. It is constructed of materials that have a long clinical history of proven acceptance and performance.
The provided text does not contain information about acceptance criteria or a study proving device performance. The document describes a 510(k) premarket notification for a dental implant, focusing on demonstrating substantial equivalence to a predicate device rather than presenting new performance study data against predefined acceptance criteria.
The information primarily details:
- Device Name: SPI® ELEMENT Dental Implant Ø 3.5 mm
- Manufacturer: Thommen Medical AG
- Classification: Class III, Endosseous Dental Implant (21 CFR 872.3640, Product Code DZE)
- Predicate Device: HA-Ti Dental Implants (K003045, K901927)
- Device Description: Two-stage root form implant, made of commercially pure grade titanium (CP Grade 4, meeting ASTM F67 and ISO 5832-2). Surface is smooth machined transgingival, sandblasted and acid-etched in bone contact area. Available in 8mm, 11mm, 14mm, 17mm lengths with a 3.5mm diameter.
- Intended Use & Indications for Use: Support for crowns, bridges, or overdentures in specific locations with adequate bone structure, with contraindications for certain applications (e.g., posterior teeth, single-tooth canines/central incisors in the upper jaw, retentive anchors).
- Similarities to Predicate: Same intended use, operating principle, basic design (with new diameter), materials, packaging, and sterilization.
- Sterilization: Co gamma irradiation at 25kGy (2.5 Mrad), validated by bioburden method per ISO 11137, with a sterility assurance level (SAL) of 10^-6.
Since the document is a 510(k) submission focused on substantial equivalence, it does not include the following details:
- Table of Acceptance Criteria and Reported Device Performance: Not present. The submission aims to show the new device is as safe and effective as a legally marketed one, not to meet specific performance metrics through a clinical trial or direct performance testing studies beyond material and sterilization standards.
- Sample Size and Data Provenance for Test Set: Not applicable as a formal performance study with a test set against acceptance criteria is not described.
- Number and Qualifications of Experts for Ground Truth: Not applicable.
- Adjudication Method: Not applicable.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned.
- Standalone (Algorithm Only) Performance Study: Not applicable as this is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set Was Established: Not applicable.
§ 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.