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510(k) Data Aggregation
(320 days)
BruxZir® NOW SRC is a pre-manufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. BruxZir® NOW SRC consists of two major parts. Specifically, the precemented titanium abutment and zirconia superstructure components make up a two-piece abutment. All digitally designed CAD/CAM customizations for BruxZZir® NOW SRC are only intended to be designed and manufactured according to digital dentistry workflow, which incorporates of the digital dentistry workflow including scan files from Intra-Oral Scanners, CAD software, milling machine and associated tooling and accessories.
BruxZir® NOW SRC is a pre-manufactured two-piece hybrid abutment crown composed of a fully sintered zirconia superstructure and a pre-installed Ti-base (titanium base) that is used with the glidewell.io™ In-Office Solution. The zirconia and Ti-base components make up a two-piece abutment, which is used in conjunction with endosseous dental implants to restore chewing function. The CAD/CAM software is intended to design the final abutment shape including anatomic features and facilitate in-office milling.
The Ti-base of BruxZir® NOW SRC is pre-cemented to a post-sintered zirconia superstructure, which is to be designed and fabricated to support screw-retained prosthetic restorations. After machining in the fastmill.io"M In-Office Mill, this two-piece abutment is mounted onto the implant and fixed with a screw. BruxZir® NOW SRC can be milled in-office by a dental professional and dental laboratories.
The digital workflow requires the use of the following equipment:
- Scanner: Intra-oral scanner
- Design Software: CloudPoint FastDesign Chairside (K231529)
- Restorative Material: Fully sintered zirconia; BruxZir® NOW(K220816)
- Milling Unit: fastmill.io™ In-Office Mill
The BruxZir® NOW SRC is designed and fabricated to be compatible with the Hahn™ Tapered Implant System (K143353) and the Inclusive® Tapered Implant System (K121406, K153099). BruxZir® NOW SRC is provided non-sterile and intended for single use and prescription use.
The provided text describes the BruxZir® NOW SRC, a dental implant abutment, and its substantial equivalence to a predicate device. It primarily focuses on mechanical, sterilization, biocompatibility, shelf-life, and packaging data to support its claims. There is no information provided in the document about acceptance criteria, device performance, AI/algorithm studies, ground truth establishment, or expert involvement. The document primarily reports on non-clinical testing.
Here's a breakdown of what CANNOT be answered based on the provided text:
- Acceptance criteria and reported device performance (in the context of clinical or AI performance): The document doesn't define specific acceptance criteria for performance metrics like sensitivity, specificity, or accuracy, as it's not evaluating an AI/diagnostic device. It broadly states the device has "sufficient strength" and provides a "maximum angulation correction of 20 degrees" based on mechanical testing.
- Sample size for test set and data provenance (for AI): Not applicable as there is no AI or clinical test set described.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used (for AI/clinical performance): Not applicable.
- Sample size for the training set (for AI): Not applicable.
- How the ground truth for the training set was established (for AI): Not applicable.
However, I can extract information about the non-clinical studies performed and their general conclusions:
Non-Clinical Studies and Findings:
| Study Category | Acceptance Criteria / Standard Followed | Reported Device Performance / Conclusion |
|---|---|---|
| Mechanical Properties | FDA Guidance Document, "Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" and ISO 14801:2016 standard. Testing performed with worst-case scenario. | The fatigue limit data demonstrated that the subject device has sufficient strength and provides a maximum angulation correction of 20 degrees for its intended use. Used to address substantial equivalence. |
| Sterilization Validation | ISO 17665-1:2006 (for steam sterilization). Compared to reference device (Inclusive® Abutments, K160979) which had previous validation. | The steam sterilization parameters previously validated for the reference device (K160979) can sufficiently sterilize the subject device for use in a clinical environment, indicating it meets the criteria. |
| Biocompatibility Evaluation | FDA Guidance Document, "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process'." | Concluded that there is no biocompatibility concern. |
| Shelf Life | Based on material stability (titanium alloy conforming to ASTM F136 and Zirconium Oxide). | Shelf-life is not applicable due to the inherent stability of the materials, and no new safety or effectiveness concerns were raised due to aging. |
| Packaging Validation | Evaluated suitability to withstand distribution environment. Compared to reference device (BruxZir® NOW, K220816). | The results of previous packaging validation for the reference device supported the packaging for the subject device, indicating it can withstand distribution without damage. |
| Use in MR Environment | FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" and published literature. | Non-clinical MR review performed using scientific rationale; indicates suitability or safety within an MR environment. (Specific parameters not detailed, but the review was conducted). |
Sample Sizes and Data Provenance for Non-Clinical Tests:
- Mechanical Testing: The document refers to "worst-case scenario" testing but does not specify the number of samples or the origin of the data. It's implicitly laboratory-based data for device components.
- Sterilization Validation: Refers to "testing sample used in the previous steam sterilization validation testing for the reference device (K160979)" which "represented the worst-case scenario." No specific number is given for the subject device itself.
- Biocompatibility Evaluation: This is a biological evaluation following ISO 10993-1. Sample size not specified.
- Shelf Life: Based on material science principles; no direct sample size for testing is implied.
- Packaging Validation: "Previous packaging validation" for a reference device was used. No specific sample size for the subject device's packaging.
- MR Environment: Based on scientific rationale and published literature; not a direct experimental study with a sample size for this submission.
Further Notes:
- The document states "No clinical data was included in this submission." This explicitly confirms that the information requested about clinical performance, expert ground truth, and reader studies is not present in this document.
- The device is a "pre-manufactured prosthetic component" for dental implants, not an AI or diagnostic software. Therefore, the questions related to AI-specific performance metrics, training/test sets, and ground truth are not applicable to the scope of this FDA submission.
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(152 days)
Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained prosthetic restorations.
All digitally designed abutments for use with Inclusive Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.
Compatible Implant System: MegaGen AnyRidge® Implant System Implant Diameter (mm) 3.5, 4.0, 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4 Platform Diameter (mm) 3.5 and 5.0
Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge Implant System are made of titanium alloy and have a prefabricated, precision interface (implant/ abutment connection) and are to be used for fabrication of patient-specific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by a Prismatik Dentalcraft authorized milling center. The proposed device is compatible with the MegaGen AnyRidge Implant System (K140091); 3.5, 4.0. 4.4, 4.9, 5.4, 5.9, 6.4, 6.9, 7.4, 7.9, 8.4mm implant diameter. Abutments are made from alloyed titanium Ti-6Al-4V ELI which meets ASTM standard F-136.
The Titanium Abutment Blanks are used for fabrication of all-titanium patient-specific abutments. These abutments include Multi-unit, Esthetic, and Straight Abutments. The Straight Abutments come in both Engaging and Non-Engaging connections. The Straight abutments 4.5 mm and 6.0 mm are used for support of CAD/CAM fabricated crowns / bridges or CAD/CAM fabricated zirconia copings. A patient-specific finished device for the 4.5 mm and 6.0 mm straight abutments will consist of both the titanium base and zirconia coping and will contain no angle correction.
The provided text describes the submission of Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System for FDA 510(k) clearance, asserting substantial equivalence to predicate devices. The study conducted is primarily non-clinical performance testing.
Here's the breakdown of the requested information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format alongside specific reported device performance values. Instead, it states that "The technological characteristics of the subject device have been verified to be essentially the same as the predicate device based on assessments of material composition, dimensional features, and mechanical properties." and that "Comparative testing was performed to show equivalence to the predicate device. This testing was performed according to ISO 14801:2007." This implies that the acceptance criteria are met if the device's performance is comparable to, or within the established range of, the predicate devices under the specified ISO standard for dental implants.
The reported device performance is that it met the requirements of ISO 14801:2007 through Reliability Calculation, Fatigue Testing, and Static Load Failure Testing.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the non-clinical tests (Reliability Calculation, Fatigue Testing, Static Load Failure Testing).
The data provenance is retrospective, as it relies on established standards and comparative testing against predicate devices. The document does not mention the country of origin of the data, but the testing was conducted to meet FDA guidance and ISO standards.
3. Number of Experts and their Qualifications for Ground Truth
This question is not applicable to this submission. The ground truth for this type of device (dental abutments) is established through objective, standardized mechanical and material testing as per ISO and FDA guidance, rather than expert consensus on interpretive data (e.g., medical images).
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, typically in diagnostic studies. For mechanical performance testing, the results are objectively measured against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient cases, often with and without AI assistance, to measure improvements in diagnostic accuracy or efficiency. The device in question is a dental abutment, and its effectiveness is determined by mechanical and material properties, not human interpretation of cases.
6. Standalone Performance Study (Algorithm Only)
No. A standalone algorithm performance study was not done. This device is a physical medical device (dental abutment), not an AI algorithm. Its performance is assessed through laboratory testing, not algorithmic output without human involvement.
7. Type of Ground Truth Used
The ground truth used for this device is based on established engineering standards and regulatory guidance. Specifically:
- ISO 14801:2007: Standard for fatigue testing of endosseous dental implants.
- FDA Guidance: "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
- Material Standards: ASTM standard F-136 for Ti-6Al-4V ELI.
- Biocompatibility Testing: Applicable prior biocompatibility testing for reference devices K121406 and K143353 (Sensitization, Cytotoxicity, and Systemic Toxicity).
These standards define the acceptable mechanical properties, material composition, and biological safety for such devices.
8. Sample Size for the Training Set
This question is not applicable. The device is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no training set for a physical dental abutment.
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