(207 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:
| Implant Platform compatibility | Platform diameter
[mm] | Implant Body diameter
[mm] |
|--------------------------------|---------------------------|--------------------------------|
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 |
The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an 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™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by 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™ 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:
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- Minimum wall thickness 0.5 mm
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- Minimum post height 4.0 mm (for single unit restorations)
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- Maximum gingival height 5.0 mm (min. GH of 0.5mm)
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- Maximum angulation 20°
The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.
The Elos Accurate® Hybrid Bas has a gold-colored anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K201860.
Some of the prosthetic screws are uncoated and two screws are Medicarb coated, identical to the Medicarb coating in predicate device K201860. The subject uncoated screws are compatible with implant platforms Zimmer Screw-vent, Biomet 3i, Neodent GM and Straumann Standard RN and WN. The subject Medicarb coated screws are compatible with the implant platforms Hiossen ET Mini and ET Regular. The purpose of the coating is to lower friction in the thread connection and the screw seat connection.
The Elos Accurate® Hybrid Base™ 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 Elos Accurate® Hybrid Base™ is a dental device intended for attaching to dental implants to provide a basis for single or multiple tooth prosthetic restorations. It acts as an interface between a dental implant and a zirconia superstructure.
Here's a breakdown of the acceptance criteria and supporting studies:
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstrates Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use (Support of a prosthesis to restore chewing function) | Substantially equivalent to predicate. |
| Abutment Designs (2-piece - zirconia bonded to hybrid base mounted on implant and fixed with a screw) | Substantially equivalent to predicate. |
| Prosthesis Attachment (Abutment screw-retained to implant, superstructure cement-retained) | Substantially equivalent to predicate. |
| Restoration (Single-unit, Multi-unit) | Substantially equivalent to predicate. |
| Abutment/Implant Platform Diameter (mm) (Up to 7.0mm, larger than predicate (3.0-6.0mm) but not a new worst-case) | Subject device supports 3.2 - 7.0mm implant diameters. The larger diameter does not represent a new worst-case scenario and thereby affects the safety of the product. |
| Abutment Angle (20° maximum) | Substantially equivalent to predicate (20° maximum). |
| Materials - Abutment (Ti-6Al-4V alloy) | Substantially equivalent to predicate. |
| Materials - Screw (Ti-6Al-4V alloy) | Substantially equivalent to predicate. |
| Materials - Zirconia superstructure (3M Lava zirconia) | Substantially equivalent to predicate. |
| Surface - Abutment (Anodized) | Subject abutment is anodized, identical to predicate. |
| Surface - Screw (Non-coated, Medicarb coated) | Medicarb coating identical to predicate. Mechanical performance demonstrated in fatigue testing. |
| Design Workflow (3Shape intra oral scanner, 3Shape Abutment Designer Software, K151455) | Substantially equivalent; specific new digital libraries validated as part of the submission. |
| Manufacturing Workflow (CORITEC milling unit) | Substantially equivalent. |
| Fatigue Testing (Per ISO 14801, FDA guidance) | Performed on subject devices, demonstrating equivalence with predicate devices. |
| Engineering and Dimensional Analysis (For compatibility with original manufacturers' components) | Performed on subject devices, confirming compatibility. |
| Sterilization Validation (Per ISO 17665-1 & ISO 17665-2, SAL of 10^-6) | Demonstrated for the device. |
| Biocompatibility (Per ISO 10993-1, ISO 10993-5 - Cytotoxicity) | Cytotoxicity test performed on a complete restoration, showing non-cytotoxic. Leveraged from previously cleared products. |
| MR Conditional Labeling | Leveraged from predicate devices (K222044). |
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Sample Size Used for the Test Set and the Data Provenance:
- Fatigue Testing: "fatigue testing was performed on the subject devices per ISO 14801." The exact number of samples tested per device type is not specified but implied to be sufficient for ISO 14801 compliance.
- Engineering and Dimensional Analysis: Performed on "original manufactures' components (abutments, implants & abutment screws)." The number of components is not specified.
- Digital Dentistry Workflow Validation/Design Limitation Test: "The digital dentistry workflow validation was completed on selected models of subject product line" and "A design limitation test is performed...". Number of models/tests not specified.
- Biocompatibility (Cytotoxicity): A cytotoxicity test was performed on "a complete restoration produced via the described validated workflow." Exact number of samples not specified.
- Data Provenance: Not explicitly stated, but the testing appears to be conducted by or for the manufacturer (Elos Medtech Pinol A/S). No information is given about the country of origin of the data or if it was retrospective or prospective in the context of clinical studies (as this is a non-clinical submission).
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Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- This submission focuses on non-clinical testing and substantial equivalence to predicate devices based on engineering and performance standards. There is no mention of "experts" establishing ground truth in the context of diagnostic performance or clinical outcomes. The "ground truth" for the engineering and material properties would be established by validated test methods and established standards (e.g., ISO 14801, ISO 10993).
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Adjudication Method for the Test Set:
- Not applicable. This is a non-clinical submission based on engineering tests and standards, not a clinical study requiring adjudication of diagnostic results.
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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:
- No MRMC study was mentioned or performed. This device is a dental implant component, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context refers to established engineering standards, material properties, and performance requirements for dental implant abutments. This includes:
- ISO 14801: "Dentistry – Implants – Dynamic fatigue test for endosseous dental implants" for fatigue testing.
- ISO 17665-1 & ISO 17665-2: For sterilization validation.
- ISO 10993-1 & ISO 10993-5: For biocompatibility (cytotoxicity).
- Engineering and dimensional analysis: Based on specifications of original manufacturers' components.
- The "ground truth" in this context refers to established engineering standards, material properties, and performance requirements for dental implant abutments. This includes:
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and does not have a "training set." The closest analogy could be the design and manufacturing parameters used to create the device, which are based on established engineering principles and prior device knowledge.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of medical device. The design and manufacturing are based on established engineering principles and validation against performance standards.
§ 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.)