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510(k) Data Aggregation
(79 days)
Nobel Biocare AG
NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.
TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with
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This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.
Therefore, I cannot provide the requested information for the following reasons:
- Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.
In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.
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(82 days)
Nobel Biocare AG
The Universal Base Conical Connection is a premanufactured prosthetic component directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. The Universal Base Conical Connection consists of two major parts. Specifically, the titanium base and mesostructure components make up a two-piece abutment. The 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 Universal Base Conical Connection is a dental implant abutment intended to be used with the current Nobel Biocare dental implants that have the existing conical connections.
The Universal Base Conical Connection features a fixed upper shape with indexing feature that is intended to serve as the platform for an in-laboratory CAD/CAM system made mesostructure. The fixed upper shape and indexing feature facilitates the use of CAD/CAM systems by providing a known shape that can be imported into the design software, thereby, simplifying the CAD/CAM design process.
The Universal Base Conical Connection is available for the Nobel Biocare Narrow Platform (NP), Regular Platform (RP) and Wide Platform (WP) for external hex. All sizes are available in either 1.5 or 3mm collar heights. The Universal Base Conical Connection is made of titanium vanadium alloy.
The provided text describes the Universal Base Conical Connection (CC) dental implant abutment and its equivalence to a predicate device, Nobel Biocare Universal Base Abutment (K180899). The text focuses on establishing substantial equivalence through mechanical, biocompatibility, software, and sterilization testing, rather than an AI-driven diagnostic device requiring extensive clinical studies with ground truth.
Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness, and training set details, are not applicable to this document. The document describes a traditional medical device (dental implant abutment) and its performance through engineering and manufacturing validation rather than a diagnostic algorithm.
Here's a summary of the information that is applicable from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several performance tests indirectly through compliance with standards. Explicit numerical acceptance criteria are not detailed in a separate table, but compliance with ISO standards and other tests serves as the acceptance criteria.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dynamic Fatigue | Compliance with ISO 14801: "Dentistry - Implants - Dynamic loading test for endosseous dental implants" | Demonstrated compliance with minimum required fatigue properties. |
| Biocompatibility | Compliance with ISO 10993-1: "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" | Successfully conducted Cytotoxicity and Chemical Characterization tests. |
| Software Verification & Validation | Demonstrated that software restrictions prevent design outside limitations; established design limitations are locked and cannot be modified. | Validation completed with 3Shape TRIOS Scanner, 3Shape Abutment Designer Software (K155415), CORTEC imes-icore milling unit workflow. Design libraries were validated. |
| Sterilization Validation | Compliance with AAMI-TIR30, ISO 17665-1, and ISO 17665-2. | Steam sterilization analysis performed, device provided non-sterile with instructions for end-user sterilization. |
| Packaging | Not a new worst case in terms of device packaging and shelf life compared to predicate. | Packaging is the same as the predicate (thermoform tray with peel-top lid). No additional testing required. |
| Restorative Design Specifications | Angle from axis of the implant: 20° Max; Wall Thickness Circular: 0.8mm min; Wall Thickness Margin: 0.275mm min; Post Height: 5.2mm min; Maximum Length, width and Height: EM-14 blank 12x14x18mm, EM-10 blank 8x10x15mm | Not explicitly stated as "passed" for all, but adherence to these specifications is implied by the product description and intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test, but standard test sizes as mandated by the referenced ISO standards would have been used. For example, ISO 14801 for dynamic fatigue testing of dental implants typically involves a specific number of samples (e.g., typically 5-10 samples per test group in some variations).
- Data Provenance: The tests are described as performance testing submitted in this 510(K) to support substantial equivalence, indicating they are internal validation studies performed by or for Nobel Biocare AG. No specific country of origin for the data or whether it was retrospective/prospective is mentioned, but typical medical device testing is prospective and conducted at qualified labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a component of a dental implant system, and its performance evaluation relies on engineering tests and compliance with recognized standards, not on expert interpretation of diagnostic images or clinical outcomes for establishing ground truth in the context of an AI algorithm.
4. Adjudication method for the test set
Not applicable for the reasons stated above.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers) and is not applicable to a dental implant abutment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical component, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by:
- Engineering measurements and material properties for mechanical strength and structural integrity.
- Chemical and biological assays for biocompatibility.
- Software validation logs and functional testing for software components.
- Sterilization cycle validation for sterile claim (or user sterilization instructions).
- Adherence to specified design parameters (e.g., angles, wall thickness).
8. The sample size for the training set
Not applicable. This device is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm.
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