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510(k) Data Aggregation
(251 days)
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.
The provided text describes the regulatory clearance of a dental implant system (N1™ TiUltra™ TCC Implant system) and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving the device meets those criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, indications for use, and comprehensive non-clinical and clinical testing. The concept of "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate, rather than meeting specific performance metrics for a diagnostic task.
Therefore, I will interpret "acceptance criteria" as the criteria for establishing substantial equivalence and "reported device performance" as the outcomes of the non-clinical and clinical studies conducted to support that equivalence.
Here's a breakdown of the information based on the provided text, addressing your specific questions, with explanations for what is not present:
1. Table of acceptance criteria and the reported device performance
Since this is a submission for substantial equivalence, the "acceptance criteria" are demonstrating similarity to predicate devices and acceptable performance in various non-clinical and clinical tests.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (N1™ TiUltra™ TCC Implant system) |
|---|---|
| Substantial Equivalence in Intended Use and Indications for Use. | N1™ TiUltra™ TCC Implant system shares the same or similar intended use and indications for use as predicate devices, with differences adequately addressed. |
| Sterilization Validation (SAL 10⁻⁶) | Successfully demonstrated sterility assurance level of 10⁻⁶ via gamma sterilization, confirming safety for use. |
| Endotoxin Levels (meeting USP , , ANSI/AAMI ST72) | Testing confirmed endotoxin levels are within acceptable limits, demonstrating pyrogen-free status. |
| End-User Cleaning & Sterilization Validation (for reusable components) | Validation performed per ISO 17665-1, AAMI TIR12, AAMI/ANSI ST79, ANSI/AAMI ST77, ISO 17664, ensuring safe reprocessing for reusable components. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Packaging Performance (maintaining sterility and device integrity) | Met standards (ISO 11607-1, ASTM D4169, D4332, F1886/F1886M, F2096, F1980), demonstrating packaging efficacy in maintaining sterility and integrity. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Biocompatibility (ISO 10993-1, -5, -12, -18) | All materials passed biocompatibility tests (cytotoxicity, chemical characterization), confirming safety for patient contact. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mechanical Resistance (ISO 14801, FDA Guidance) | Demonstrated sufficient fatigue resistance and mechanical stability in dynamic loading tests, comparable to predicate devices. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Insertion Parameters (Heat Generation, Torque) | Comparative testing demonstrated equivalence in heat generation and insertion torque to the Primary Predicate, indicating similar surgical experience and bone response. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Osseointegration (Animal Study) | Animal study showed representative osseointegration behavior comparable to the predicate (TiUltra Implants and Xeal Abutments) at 13 ± 2 weeks, supporting the new drilling technique. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mesostructure Design & Manufacturing (Software & E2E Validation) | Software verification for abutment design library ensured adherence to design limitations; validation confirmed locked specifications, and end-to-end (E2E) validation demonstrated proper manufacturing workflow. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| MR Conditional Labeling (Referencing K212125) | Met acceptable outcomes in MR conditional testing for safe use in specific MR environments, leveraging prior clearance. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Long-term Clinical Performance (MBLC, Survival, Safety, Tissue Health) | Primary Endpoint (MBLC): Non-inferiority to historical data for the predicate device (NobelActive implant system) was met with statistical significance (p |
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(79 days)
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
Not Found
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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