Search Results

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:

1. 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.
2. 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.

Ask a specific question about this device

The Promimic AB, Promimic Dental Implant is intended for surgical placement into the bone of upper/ lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function. The Promimic Dental Implant can be immediately loaded only with good primary stability and appropriate occlusal loading. The Promimic Dental Implants are only to be used with straight abutments.

The Promimic Dental Implant consists of 4 implants, diameter 3.75 mm, and length from 8.5 to 15.0 mm.

Here's a breakdown of the acceptance criteria and study information for the Promimic Dental Implant, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative "acceptance criteria" for the Promimic Dental Implant's performance. Instead, it uses a substantial equivalence (SE) approach, comparing its characteristics to previously cleared predicate devices. The "acceptance" is based on demonstrating that the new device's technological characteristics are similar to the predicates and that any differences do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• The document does not report specific sample sizes for a "test set" in the context of clinical or performance data for the Promimic Dental Implant itself. The performance testing mentioned refers to mechanical testing, not clinical trials on human subjects.
• The data provenance pertains to mechanical testing performed by Promimic AB to demonstrate the physical properties of the device. There's no mention of country of origin for clinical data or whether it's retrospective or prospective, as clinical data for this specific device is not presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable or not provided in the context of this 510(k) summary. The "ground truth" for showing substantial equivalence relies on comparing the device's technical specifications and mechanical testing results to established predicate devices and recognized standards, not on expert adjudication of clinical outcomes for a test set.

4. Adjudication Method for the Test Set

• This information is not applicable or not provided. There is no mention of a clinical "test set" requiring adjudication by experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This is not applicable. The Promimic Dental Implant is a physical medical device (dental implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

• This is not applicable. As stated, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the substantial equivalence determination is the technical specifications and established performance characteristics of legally marketed predicate devices and compliance with recognized mechanical testing guidelines (specifically, "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated May 12, 2004").

8. The Sample Size for the Training Set

• This information is not applicable or not provided. There is no "training set" in the context of developing this physical medical device. The manufacturing processes and design are based on established engineering principles and materials science.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable or not provided. There is no "training set" or corresponding ground truth for this type of device submission.

Ask a specific question about this device

The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are intended to be used as accessories in conjunction with the Wide Platform endosseous implant system and in the exact same manner as their counterpart predicate product.

The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are components used with various BRANEMARK SYSTEM® Wide Platform Fixtures. They include Abutments, Healing Abutments, Hand Instruments, Impression Copings and Machine Instruments.

This document is a 510(k) summary for a medical device submitted in 1996. It does not contain any information about acceptance criteria, device performance, results of any studies, or ground truth establishment.

The document is a pre-market notification that primarily focuses on:

• Device Name and Manufacturer: Nobelpharma USA, Inc.
• Device Description: Accessories for the BRANEMARK SYSTEM® - Wide Platform Fixtures (e.g., Hand Instruments, Healing Abutments, Impression Copings, Machine Instruments).
• Predicate Product: Other existing components marketed by Nobelpharma.
• Intended Use: To be used as accessories with the Wide Platform endosseous implant system, in the same manner as predicate products.
• Comparison of Technological Characteristics: States that the technological characteristics are "identical" to the corresponding predicate products.

Therefore, I cannot provide the requested information as it is not present in the provided text.

To answer your questions, I would need a document that describes the design verification and validation testing performed for the device, including:

• Specific acceptance criteria (e.g., tensile strength, dimensional accuracy, sterilization efficacy).
• Results of tests demonstrating compliance with these criteria.
• Details about the study design (e.g., sample sizes, methods for establishing ground truth, expert qualifications, adjudication methods).

Ask a specific question about this device