(162 days)
The Angled Tapered Abutment is used for a terminal or intermediate abutment for screw-retained multiple-unit restorations. The 30°Angled Tapered Abutment must be used within 45 degree of parallelism for a splinted restoration. The 15°Angled Tapered Abutment must be used within 30 degrees of parallelism for a splinted restoration.
The Angled Tapered Abutment has an external hex which engages the hex of the Tapered Screw-Vent and Screw-Vent implant. The abutments are available in multiple cuff heights and in both 15° and 30° configurations to provide angulation correction for off-angle implant placement. The abutment is secured to the implant with an abutment retaining screw. The abutment screw is preassembled in the abutment and is not removable from the abutment. The abutment has a tapered cone with an internal screw access for the attachment of various restorative components using a separate coping screw. The abutment cone has a 15° taper and is 1.2mm tall. Abutments are packaged with a metal delivery tool to assist with the placement and orientation of the abutment into the implant. The abutment and abutment retaining screw are fabricated from titanium allov.
The current tapered abutments facilitate multiple-unit, screw-retained restoration. These abutments do not engage the internal hex.connection. and are not for use in single-unit. While the current tapered abutments are somewhat limited to straight restoration, the new device will expand the functionality of our screw retained restoration by permitting angled restoration. It will be available in titanium 6Al-4V and will provide an angulation up to 30°.
The Angled Tapered Abutment is a dental device intended for use as a terminal or intermediate abutment in screw-retained multiple-unit restorations. The acceptance criteria and the study conducted to demonstrate the device's performance are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria |
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| Mechanical Performance: The device must demonstrate sufficient strength and integrity to withstand anticipated forces encountered in the oral environment. This includes resistance to fatigue and compression. Results are expected to be comparable to or better than predicate devices. | Achieved: Non-clinical testing, including fatigue and compression testing, was performed in accordance with FDA guidance "Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments." The testing "indicates that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device." |
| Material Equivalence: The device material must be equivalent to predicate devices for biocompatibility and mechanical properties. | Achieved: The Angled Tapered Abutment is fabricated from Titanium 6Al-4V, which is the same material as the predicate NobelActive Multi Unit Abutment and Tapered Abutment. |
| Implant/Abutment Connection Equivalence: The connection mechanism between the abutment and implant should be equivalent to predicate devices to ensure proper fit and function. | Achieved: The Angled Tapered Abutment's method of attachment (internal screw threaded through internal hex into implant) is equivalent to both predicate devices. |
| Abutment Platforms Equivalence: The available abutment platforms should be comparable to existing devices to maintain compatibility with restorative components. | Achieved: The new device offers 3.5, 4.5mm platforms, which are comparable to the 3.5, 3.9mm of Predicate No. 1 and 3.5, 4.5, 5.7mm of Predicate No. 2. |
| Angulation Capability: The device must provide the specified angulation correction (15° and 30° configurations) for off-angle implant placement. | Achieved: The device is available in 15° and 30° configurations, providing angulation up to 30°, similar to Predicate No. 1. Predicate No. 2 had 0° angulation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific non-clinical tests. The document indicates that "Non-clinical test data was used," implying a sufficient number of samples were tested to meet the guidance. Specific quantities for each test (e.g., number of abutments for fatigue testing) are not detailed.
- Data Provenance: The data is from non-clinical testing performed by Zimmer-Dental-Inc. within the United States. It is prospective testing, as it was conducted specifically to gather performance data for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is Not Applicable as the study did not involve human experts establishing ground truth. The acceptance criteria were based on objective engineering and material performance standards (e.g., strength, material composition) and compliance with regulatory guidance.
4. Adjudication Method for the Test Set
This section is Not Applicable as the study involved objective non-clinical testing against predefined engineering standards, rather than human review or adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This section is Not Applicable. The study describes the performance of a physical dental abutment and does not involve AI, human readers, or clinical imaging.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is Not Applicable, as the device is a physical dental abutment, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was defined by established engineering standards and regulatory guidance documents. Specifically, performance tests were conducted "in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments." This guidance provides objective criteria and methodologies for assessing the safety and effectiveness of such devices.
8. The Sample Size for the Training Set
This section is Not Applicable. The study involves physical device testing, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is Not Applicable, as there was no training set.
§ 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.)