Search Results
Found 5 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
(539 days)
The NSS-nonsubmerged implant system. These implants and prosthetic implant systems are to be used for the reconstruction of partial and totally edentulous implant patients. The implants are to be used in single or multiple units in the edentulous regions of the maxilla and mandible. The indications range from single tooth application, implant supported partial denture, implant supported bar/overdenture, implant retained overdenture, fixed-detachable implant prosthesis, and totally edentulous implant retained prosthetic designs. The diameter changes of the implant system are to correspond with the maximum available bone width in the treatment areas. Large diameter implants can be utilized to engage the greatest amount of bone volume. These implants can also be used in a submerged protocol if the tissue is thick and a short healing cover screw is utilized. The nonsubmerged protocol does not imply immediate loading, and the implants should integrate in a 3-8 month healing phase based on the bone density before prosthetic load is incorporated into the implant sites.
Endosseous implant system consists of implants, tools and prosthetic abutments. This submission includes premachine angulated abutments less than 30°, specifically included are 15 and 25° abutments. In addition, in the wide body series there are a series of one and two piece prosthetic abutments with 4, 5, and 6mm platform diameters. These diameters match with the platform diameters of the appropriate implant bodies included in this system. This system includes cylindrical and screw implants of a variety of lengths and geometrical shapes. These devices are similar in their intended use and follow the appropriate integration protocol phase and following prosthetic attachments.
The provided text is a 510(k) summary for a medical device (endosseous implant system), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include detailed studies with acceptance criteria and performance data as would be found in a clinical trial or performance study report for a novel device.
The document primarily focuses on demonstrating substantial equivalence to existing devices based on design, materials, manufacturing processes, gamma sterilization, geometry, and materials. There are no specific acceptance criteria or details of a study explicitly proving the device meets performance criteria in the way a diagnostic AI device or a novel therapeutic device would.
Therefore, many of the requested elements for the acceptance criteria and study section cannot be extracted directly from this 510(k) summary.
Here's what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics are provided in the document. The substantial equivalence is based on the device being "similar to the predicate devices currently on the market" in its characteristics and intended use.
2. Sample size used for the test set and the data provenance
No test set or data provenance is mentioned. This is a premarket notification for a device based on similarity to predicate devices, not a study reporting performance data on a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set or ground truth establishment process is described.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is described.
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
Not applicable. This is not an AI-assisted device, and no MRMC study content is present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is mentioned. The device's safety and effectiveness are established through substantial equivalence to predicate devices, implying that past clinical experience and regulatory approvals of similar devices form the basis.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set or ground truth establishment for a training set is described.
Ask a specific question about this device
(190 days)
The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient.
system consists of Endosseous implant implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.
This document is a 510(k) summary for a dental implant system. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, manufacturing process, and intended use. It does not present performance data or clinical study results in the manner requested.
Therefore, I cannot provide the requested information.
Ask a specific question about this device
(190 days)
The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for for the patient.
Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.
This document is a 510(k) summary for dental implant abutments, intended to demonstrate substantial equivalence to predicate devices already on the market. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.
The document discusses:
- Predicate Devices: Lists specific 510(k) numbers for previously cleared dental implant systems.
- Device Description: Describes the endosseous implant system, focusing on pre-machined angulated abutments (15 and 25-degree) and wide-body abutments (4, 5, and 6 mm platform diameters).
- Intended Use: To facilitate the prosthetic phase and installation of a prosthesis for the patient.
- Technology Characteristic Summary: States that design, material, manufacturing process, sterilization, geometry, and service are similar to predicate devices. Materials used are ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5. It also mentions compliance with GMP guidelines.
Therefore, I cannot provide the requested information about acceptance criteria or a study demonstrating device performance because it is not present in the provided text. The document's purpose is to establish substantial equivalence for market clearance, not to detail performance studies against specific acceptance criteria.
Ask a specific question about this device
(76 days)
The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the proBthetic phase and installation of the programs of the program and 824 U.S. Highway 1, Suite 370 1499 W. Palmetto Park Road Boca Raton 33486-3311 N. Palm Beach, Florida 33408 (407) 392-4747 (407) 627-5560 FAX (407) 392-8320 FAX (407) 627-4214 "Tomorrow's Technology Today"
Endosseous implant system consists of implants, tools and This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.
This document is a 510(k) summary for an endosseous implant system, specifically focusing on wide body and pre-angled abutments. It primarily establishes substantial equivalence to predicate devices and does not describe a clinical study or performance testing against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be found in this document.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance
- None stated: The document does not define specific quantitative acceptance criteria or report on device performance against such metrics. Its focus is on demonstrating substantial equivalence to predicate devices.
Study Details
As no specific study is described in this 510(k) summary, the following information is not available:
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Information that is available in the document:
- Device Description:
- Consists of implants, tools, and pre-machined angulated abutments (15 and 25-degree).
- Includes wide-body abutments of one and two-piece prosthetic designs with 4, 5, and 6 mm platform diameters.
- Placed on top of implant fixtures after integration.
- Intended Use:
- Similar to other implant systems.
- To facilitate the prosthetic phase and installation of prostheses.
- Technology Characteristic Summary:
- Material, manufacturing process, gamma sterilization, design, geometry, and services are similar to predicate devices.
- Materials: ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5.
- GMP guidelines are in place and have been inspected by the FDA Office of Compliance.
- Predicate Devices:
In summary, this document serves as a regulatory submission demonstrating substantial equivalence through comparison to existing devices, rather than presenting data from a clinical performance study with predefined acceptance criteria.
Ask a specific question about this device
Page 1 of 1