Search Results
Found 1 results
510(k) Data Aggregation
(132 days)
Legacy SMARTBase Abutments
The Legacy™ SMARTBase Abutment system is designed to be used in support of a dental implant(s) to provide support for prosthetic restorations in a partially edentulous patient. Legacy SMARTBase engaging abutments are intended for use in the mandible or maxilla in support of single unit restorations.
The Legacy SMARTBase Abutment system integrates multiple components for use in both a traditional and digital dentistry workflow: scan files from Intra-oral Scanners and lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. The Legacy SMARTBase system consist of two major parts: the titanium base and zirconia top components make up a two-piece abutment.
- . Legacy SMARTBase abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
- Legacy SMARTBase abutment for short (8mm) 3.7mmD implants: Indicated for tooth . replacement of mandibular and maxillary central and lateral incisors.
The Legacy SMARTBase Abutment is a two-piece engaging dental implant abutment comprised of a titanium base and a zirconia top (which can be supplied with the base or acquired separately by the customer). The abutments are offered in three widths (narrow, regular, and wide), platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm, and collar (titanium base) heights of 0.25, 1.0, and 2.0 mm in order to accommodate different patient anatomies. The device is supplied with fixation screws that function as an extension of the implant to which the SMARTBase is secured, and is used with several accessories in conventional and digital workflows to fabricate the patient-specific restorations, including scan adapters, implant analogs, and off-axis tools.
The Legacy SMARTBase Abutments allow for patient-specific designs through conventional and digital restoration materials and methods. The final restorations are designed and produced under the direction of a clinical professional and are based on requirements provided to Implant Direct or the preferred laboratory in digital or stone model form. The restoration (crown) is designed to fit on top of the SMARTBase abutment using off-the-shelf 3Shape software (K151455). The reference device, 3Shape Abutment Designer Software (product code PNP), provides the digital design as an accessory to the physical dental abutment. The CAD design requires loading of the Implant Direct abutment design library via the 3Shape server to the 3Shape Software in order to design the zirconia top component within the established design limitations and specifications. The 3Shape software provides a digital design output file that is used for fabricating the finished device.
The digital workflow includes the following products (not subject devices to this submission):
- Ceramic material: Zenostar MT ●
- Cement: EMBRACE Wetbond Resin Cement (K071278) ●
- Intra-oral scanner: 3M Tru-Definition (K122467), ITero Scanner (K131101) .
- Lab scanner: 3Shape D700 & 3Shape Scan-it Restoration Dental System (510(k) exempt, . product code NOF)
- . Abutment design software: 3Shape Abutment Designer™ Software (K151455)
- Milling machine: Wieland-Zenotec Select & Zenotec CAM .
The device is single-use and supplied non-sterilization by the end user. It is an externallycommunicating device which comes in permanent contact (>30 days) with a patient's tissue/bone.
This document describes Implant Direct Sybron Manufacturing, LLC's Legacy™ SMARTBase Abutments, a dental device intended to provide support for prosthetic restorations in partially edentulous patients. The FDA's 510(k) summary provides information on acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Characteristic | Acceptance Criteria (based on predicate equivalence and established standards) | Reported Device Performance |
|---|---|---|
| Mechanical Strength (Fatigue) | Equivalency to the predicate device per ISO 14801:2016 (consistent with FDA's Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Abutments). | Results confirmed that the Legacy SMARTBase abutments perform equivalently to the predicate device. (Specific quantitative results, like fatigue limits, are not provided in this summary, but the general statement confirms meeting the equivalency criterion.) |
| Biocompatibility | Meet requirements according to ISO 10993-1 and FDA's corresponding June 2016 guidance for an externally-communicating device with permanent contact (>30 days) with patient bone/tissue/blood. Standards applied include ISO 10993-2, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, and ISO 10993-33. | Demonstrated that the devices met biocompatibility requirements for its intended use. (Specific test results like cytotoxicity, irritation, or sensitization indices are not provided, but the statement indicates successful completion according to the standards.) |
| Cleaning and Steam Sterilization Validation | Attainment of a sterility assurance level (SAL) of 10^-6 using the same steam sterilization processes as the predicate device, according to ISO 14947 and ISO 17665-1. | Demonstrated attainment of a sterility assurance level of 10^-6 using the same steam sterilization processes as the predicate device. (Confirms the validated sterilization process achieves the required SAL.) |
| Software Validation (associated CAD/CAM system) | Ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments employing 3Shape software within established design limitations and specifications. | Ensured the ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments employing 3Shape software within established design limitations and specification. (States successful validation, relying on previous validation for the predicate device as the same software and milling unit are used.) |
| Intended Use / Indications for Use | Consistent with, or narrowing of, the predicate device's intended use and indications, without raising different questions of safety or effectiveness. | The Legacy SMARTBase Abutments have the same intended use and similar indications for use as the predicate. Differences either narrow its use or clarify appropriate conditions of use. The target population/conditions are fully encompassed by the predicate. Inclusion of lab scanners is an editorial change. Compatibility with the Legacy implant line (vs. InterActive for predicate) was previously cleared in a reference device. This indicates the device meets the functional equivalence criterion for its intended use. |
| Technological Characteristics | Similar technological elements to the predicate device, including two-piece abutments (titanium base, zirconia top), use in conventional/digital workflows, and similar fundamental design (size, diameter, post height). The main difference (abutment-implant interface) must be addressed by performance data. | Both the subject and predicate devices are two-piece abutments (titanium base, zirconia top), used in conventional and digital workflows with similar auxiliary devices, and feature the same fundamental design. Performance data (fatigue testing) specifically addressed the abutment-implant interface difference by showing equivalency to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each non-clinical test (mechanical fatigue, biocompatibility, sterilization validation). However, it mentions that dynamic fatigue testing was performed on "worst-case device configurations" per ISO 14801:2016.
- Test Set Sample Size: Not explicitly stated for each test, but "worst-case device configurations" were used for fatigue testing.
- Data Provenance: The studies are non-clinical (laboratory testing) performed internally by the manufacturer or by third-party labs following international standards (ISO) and FDA guidance. The country of origin of the data is not specified beyond being part of the manufacturer's submission to the FDA. The data is prospective as it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the studies are non-clinical, laboratory-based tests for physical, chemical, and biological properties of the device. There is no human "test set" requiring expert ground truth establishment in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are non-clinical laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The nonclinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Thus, clinical testing has not been conducted on this product."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is geared towards AI/software performance. While software validation was performed for the associated CAD/CAM software, it is not an "algorithm only" performance study in the typical sense of AI diagnostics. The software (3Shape Abutment Designer Software) is a design tool for the abutment, not a standalone diagnostic or predictive algorithm. Its validation "ensured the ability of the system to scan the articulator and design the model to configure to the user's need to successfully create abutments." This implies a validation of its function within the design workflow, rather than a standalone performance metric for a decision-making algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Mechanical Strength (Fatigue): Ground truth is established by the specified loads and cycles in ISO 14801:2016 and the equivalency standard to the predicate device. The "ground truth" is a pass/fail against these engineering standards.
- Biocompatibility: Ground truth is established by the pass/fail criteria defined in the referenced ISO 10993 series standards.
- Sterilization Validation: Ground truth is established by achieving a verified sterility assurance level of 10^-6 according to ISO 14947 and ISO 17665-1.
- Software Validation: Ground truth is established by the software's ability to "successfully create abutments employing 3Shape software within established design limitations and specification." This refers to functional correctness and adherence to design parameters.
8. The Sample Size for the Training Set
This document does not describe the development or training of an AI algorithm in the traditional sense, so there is no training set sample size mentioned. The CAD/CAM software mentioned (3Shape Abutment Designer Software) is an off-the-shelf product with an existing design library, not something that appears to have been "trained" by this manufacturer on a specific dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit training set for an AI algorithm described for the device itself, this question is not applicable. The software validation relies on the established functional specifications and design limitations of the 3Shape software and Implant Direct's abutment design library.
Ask a specific question about this device
Page 1 of 1