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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:

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.

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TRINON Titanium QZA and RS Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacement to restore patient esthetics and chewing function.

TRINON Titanium QZA and RS Dental Implants are indicated for single or multiple unit restorations in non-splinted applications. This can be achieved by a 2-stage surgical technique in combination with delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique.

TRINON Titanium QZA Dental Implants with a diameter of 3.3 mm may only be used in the upper jaw as a single tooth replacement of the lateral incisors and in the lower jaw as a single tooth replacement of the lateral and central incisors.

TRINON QZA and RS abutments are used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients.

QZA abutment models with an angulation of 30° are indicated for multi-unit loading, such as bridges or overdentures.

TRINON Titanium QZA Dental Implants are made of titanium grade 5. These are two-stage implants. They have a hexagonal internal cone connection and a spiralock internal thread design. Furthermore, QZA Dental Implants have micro threads in cortical part.

TRINON Titanium QZA Dental Abutments are also called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct QZA Dental Implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedures in the IFU.

The RS Implants are made of titanium Grade 5. The RS Dental Implants are two-stage implants and are available in 4 diameters for ideal implant selection and four easily identifiable platforms for efficient prosthetic restoration (color-coding). All diameters are available in lengths of 8.5 mm, 10 mm, 11.5 mm, 14.5 mm and 16 mm.

The RS Dental Implants have a conical hexagonal interlock. The RS Dental Implants are selftapping high torque arrow-shaped implants with counterclockwise self-tapping function. RS Dental implants have micro threads in cortical part of the implant feature.

The RS Abutments are made of titanium Grade 5. These are usually called prosthetic implant abutments. The connection part of the abutment is color-coded for identification with the correct RS dental implant. All abutments are delivered in unsterile conditions and have to be sterilized before use according the validated procedure descripted in the IFU.

The provided text describes a 510(k) premarket notification for the TRINON Titanium QZA and RS Dental Implant Systems. This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, rather than proving its effectiveness through clinical trials with specific performance metrics.

Therefore, the acceptance criteria and study information, as commonly sought for AI/ML device performance, are not explicitly present in the provided text. The document focuses on demonstrating substantial equivalence through comparisons with predicate devices and performance bench testing rather than clinical study outcomes.

However, I can extract information related to the performance data presented (bench tests and biocompatibility).

Here's an interpretation based on the provided text, addressing the points where information is available or noting its absence:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., success rates, complication rates) for a study proving effectiveness. Instead, it relies on demonstrating substantial equivalence to predicate devices and acceptable results from specific bench tests and biocompatibility studies.

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The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the healing period and prior to final restoration. The Temporary Snap Abutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutment is not to exceed one hundred and eighty (180) days.

The Temporary Snap Abutments are premanufactured dental implant abutments directly connected to endosseous dental implants and are intended for use as a temporary aid in prosthetic rehabilitation. The Temporary Snap Abutments are available in engaging and non-engaging connection designs and with collar heights of 1.5 and 3.0 mm. The Temporary Snap Abutments are compatible with the Nobel Biocare dental implants that have the Narrow Platform (NP), Regular Platform (RP) or Wide Platforms (WP) internal conical connection.

While the provided document is a 510(k) premarket notification for a medical device (Temporary Snap Abutment), it does not contain the information required to answer your request about acceptance criteria and a study proving the device meets those criteria.

Here's why and what the document does provide:

• Type of Document: This is a submission to the FDA seeking a determination of "substantial equivalence" to a predicate device. This process focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate, often by showing it has the same technological characteristics or that any differences do not raise new questions of safety or effectiveness. It typically relies on comparison to existing devices and performance data from those predicates, rather than extensive de novo clinical trials or detailed performance metrics for the new device itself.

• Missing Information:

  1. Acceptance Criteria Table: There is no table of acceptance criteria for the Temporary Snap Abutment's performance. The document focuses on comparing its technological characteristics and intended use to predicate devices.
  2. Reported Device Performance: While "Summary of Non-Clinical Testing" is mentioned, it only discusses biocompatibility and sterilization validations, leveraging data from the predicate. It does not provide specific performance metrics for the Temporary Snap Abutment itself (e.g., strength, durability, fit, etc.) Nor does it describe a study that directly tests these performance aspects of the subject device against specific acceptance criteria.
  3. Sample Sizes and Data Provenance for Test Set: Not applicable, as there's no described performance study for the subject device. The biocompatibility and sterilization "testing" mentioned doesn't involve a test set in the way a clinical or performance study would.
  4. Number of Experts/Qualifications for Ground Truth: Not applicable, as there's no ground truth establishment for a performance study of the subject device.
  5. Adjudication Method: Not applicable.
  6. MRMC Comparative Effectiveness Study: There is no mention of an MRMC study.
  7. Standalone Performance: While non-clinical testing for biocompatibility and sterilization is mentioned, it's not a "standalone performance" study in the sense of demonstrating the device's functional efficacy or safety attributes as a new device against specific criteria. Instead, it leverages predicate data.
  8. Type of Ground Truth: Not applicable.
  9. Training Set Sample Size/Ground Truth for Training: Not applicable, as this document is not describing a machine learning or AI device that would have a training set.

What the document does state regarding performance/testing:

The document states that the subject device does not represent a new worst case compared to the predicate (K133731). Therefore, data from the predicate was leveraged for:

• Device Packaging: Same as predicate, no additional testing required.
• Biocompatibility: Subject device is made from the same material (titanium vanadium alloy ASTM F136 and ASTM F1472) using the same manufacturing method, has the same intended use and patient contact type/duration as the predicate. Cytotoxicity and GC-MS analysis were performed in accordance with EN ISO 10993-1 (a standard), confirming no leachables or cytotoxic effect. No additional testing was required for the subject device itself beyond this.
• Sterilization: Validations were performed to ensure sterility of the subject devices when processed by the end user. These were done using autoclaves with fractionated prevacuum and gravity specific air displacement, with worst-case dental devices as described in AAMI TIR12: 2010.

In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence through comparison of design features, materials, and intended use to legally marketed predicate devices, along with leveraging existing biocompatibility and sterilization data from analogous devices or standard testing protocols, rather than presenting a detailed study of the subject device's performance against specific, quantifiable acceptance criteria.

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