(206 days)
TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:
• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
TruBase is a titanium component that is directly connected to endosseous dental implants to patientspecific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cementretained single tooth and bridge restorations. It is compatible with the following systems:
- · Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular)
- · Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm
- · BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0. 3.4, 3.8 mm
- · Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.
TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:
(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.
TruBase consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. The system also includes a TruBase Screw for fixation to the implant body.
TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in a various prosthetic platform diameters (OSSTEM TSIII SA 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) and Astra EV 3.6, 4.2, 4.8, 5.4mm and BioHorizons Internal 3.0. 3.5. 4.5. 5.7mm and Straumann Tissue Level: 4.1(RN), 4.8(RN), 6.5(WN). The TruBase Screws are composed of titanium alloy per ASTM F136.
CAD/CAM customized superstructure that composes the final abutment intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.
The provided text describes a 510(k) premarket notification for two dental devices, TruAbutment DS and TruBase. The submission asserts substantial equivalence to a predicate device based on material, intended use, and mechanical testing. The document focuses on regulatory compliance and mechanical performance, rather than clinical efficacy measured by expert assessments or comparative effectiveness studies with human readers.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established international standards for dental implants and abutments and ensuring mechanical integrity. The reported performance indicates that the devices met these criteria.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Fatigue Test per ISO 14801:2016 | Met the criteria of the standard. Fatigue limit data for all implant lines demonstrated construct strengths suitable for intended use. |
| Sterilization | End User Steam Sterilization Test per ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010 | Met the criteria of the standard (leveraged from predicate device). The performed validation method is the same as the predicate devices. |
| Biocompatibility | Biocompatibility tests per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 | Met the criteria of the standard (leveraged from predicate device). |
| Material Composition | Ti-6A1-4V ELI (meets ASTM Standard F-136) for abutment and screws | Devices are made of Ti-6Al-4V ELI, conforming to ASTM F136. |
| Dimensional Compatibility | Assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images for implant-to-abutment connection. | Testing demonstrated implant to abutment compatibility and established substantial equivalency. |
| MRI Safety | Worst-case MRI review using scientific rationale and published literature (e.g., Woods et al. 2019) addressing magnetically induced displacement force and torque based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." | Rationale addressed parameters and supports safety in the MRI environment (no specific performance metric, but rather a successful review). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state a sample size for the mechanical fatigue testing beyond "worst-case constructs." For other tests (sterilization, biocompatibility, MRI review), specific sample sizes are not provided, though these are typically laboratory-based tests rather than patient-data-based studies.
- Data Provenance: The document does not specify the country of origin for any data or whether the data is retrospective or prospective. The studies mentioned (e.g., fatigue testing, sterilization) are engineering and laboratory tests, not clinical studies involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the provided document. The studies described are non-clinical (mechanical, sterilization, biocompatibility, MRI safety) and rely on testing against established engineering and safety standards, rather than expert interpretation of a 'ground truth' in a clinical context.
4. Adjudication Method for the Test Set
This information is not applicable as the described studies are non-clinical laboratory tests and material/design assessments, not studies involving human judgment or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The submission relates to dental abutments, which are physical medical devices, and does not involve AI or image-based diagnostics requiring human reader performance studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the non-clinical tests is based on:
- Established international and national standards (e.g., ISO 14801, ISO 17665, ISO 10993, ASTM F-136, ANSI/AAMI ST79).
- Engineering specifications and design limits (e.g., minimum thickness, maximum angle for abutments).
- Physical measurements and compatibility assessments (e.g., dimensional analysis and reverse engineering of implant-to-abutment connections).
- Scientific rationale and published literature for MRI safety.
8. The Sample Size for the Training Set
This information is not applicable. The devices are physical dental abutments, not AI models that require training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI model.
In summary, the provided document focuses on demonstrating the substantial equivalence of physical medical devices through adherence to established engineering and safety standards, rather than clinical performance based on human reader assessments or AI model evaluations.
§ 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.)