(152 days)
The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.
The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1: Table 1.
| Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] |
|---|---|---|
| Astra Tech EV 3.0 | Ø3 | Ø3 |
| Astra Tech EV 3.6 | Ø3.6 | Ø3.6 |
| Astra Tech EV 4.2 | Ø4.2 | Ø3.6 & Ø4.2 |
| Astra Tech EV 4.8 | Ø4.8 | Ø4.2 & Ø4.8 |
| Astra Tech EV 5.4 | Ø5.4 | Ø5.4 |
The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software. CAM software, ceramic material, milling machine and associated tooling and accessories,
The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ functions as an interface between a dental implant and a zirconia superstructure. It attaches to the implant using the included prosthetic screw and connects to the zirconia superstructure through cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.
The Elos Accurate® Hybrid Base™ is available for two types: Engaging and Non-Engaging.
- The Hybrid Base™ Engaging which is intended for single tooth dental restorations and having an indexing feature. which avoid the Hybrid Base from rotating in the implant.
- -The Hybrid Base™ Non-Engaging is intended for multiple tooth dental restorations and has no indexing feature, which allows the Hybrid Base to rotate in the implant.
The Elos Accurate® Hybrid Base™ is available with 4 different collar heights and is provided with a 7,5mm chimney which can be cut down to several heights by the user, to minimum 3,5 mm.
The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:
| Hybrid Base abutments (zirconia part): |
|---|
| Min. wall thickness 0.5 mm |
| Gingival height min. 0.5mm or max. 5 mm |
| Max. angulation 20°. |
| Min. post height* 4 mm |
*The post height is defined as the cementable height of the abutment.
The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.
The Prosthetic Screw, also made of Titanium Alloy (ASTM F136), provided for the Elos Accurate® Hybrid Base™ is used to secure the final prosthetic restoration to the implant in the patient's mouth. The Prosthetic Screws have a hexalobular driver connection interface. The intended driver to be used with the Elos Accurate® Hexalobular Prosthetic Screws is the Elos Accurate® Prosthetic Screwdriver 18mm, 26mm or 34mm (Ref. No. PS-AH18-1, PS-AH26-1 or PS-AH34-1). These screwdrivers are Class I Exempt devices per FDA product code NDP.
The Elos Accurate® Hybrid Base has a gold anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K230317.
The subject prosthetic screws are provided anodized identical to reference device K120414.
The Elos Accurate® Hybrid Base™ and the Prosthetic screw is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient. The recommended sterilization procedure is full cycle pre-vacuum steam sterilization at a temperature of 132 °C (270°F) for 4 minutes. Dry time: 20 minutes.
The Elos Accurate® Hybrid Base™ is sold in 1 pc. packaging and the Elos Accurate® Prosthetic screw is sold in 1 pc. packaging.
The provided text does not describe an AI medical device. It is a 510(k) summary for a dental implant component, the Elos Accurate® Hybrid Base™. Therefore, it is impossible to extract the requested information about acceptance criteria and a study proving an AI device meets those criteria.
The document focuses on demonstrating the substantial equivalence of the Elos Accurate® Hybrid Base™ to a predicate device, primarily through:
- Similar Indications for Use and Intended Use: The device serves the same purpose as existing products.
- Comparable Design and Materials: It uses similar components (titanium alloy, zirconia) and design principles.
- Non-Clinical Testing: Fatigue testing (meeting ISO 14801), engineering and dimensional analysis, sterilization validation, digital dentistry workflow validation, and biocompatibility testing were performed. The fatigue testing is the closest parallel to performance testing, but it's for mechanical durability rather than diagnostic or analytical accuracy.
There is no mention of an algorithm, AI, machine learning, or any form of software that provides diagnostic or analytical outputs. Consequently, none of the specific questions about AI device performance metrics, training sets, ground truth establishment, or multi-reader studies can be answered from this document.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)