Search Results

The bredent denture relining, repairing or rebasing resin is intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base.

Dentaplast hot is a polymerizing denture resin on the basis of methylmetacrylate. Dentaplast hot allows to obtain extended processing time and offers fine flowability and is therefore matched with the Dentaplast hot casting sstem. The catalyst is free from tertiary amine and ensures high colour stability. Dentaplast is entirely cadmium-free.

Application range:

-Fabrication of full dentures in the resin casting technique

-Completion of CoCr dentures

-Relinings and shaping of functional margins

-any type of repair work such as cracks, fractures.

The provided text doesn't contain information about acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical or performance study with quantitative metrics. The document is a 510(k) summary for a dental resin, focusing on establishing substantial equivalence to a predicate device.

Here's an analysis of why the requested information isn't available in the text and what is provided:

Missing Information (and why):

• 1. A table of acceptance criteria and the reported device performance: This type of performance data (e.g., accuracy, sensitivity, specificity, specific physical properties with thresholds) is not presented. The submission relies on establishing similarity to a predicate device.
• 2. Sample size used for the test set and the data provenance: No specific test set data is mentioned.
• 3. Number of experts used to establish the ground truth... and their qualifications: No expert review process for a test set is described.
• 4. Adjudication method: Not applicable as there's no expert review.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No such study is mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a dental material, not an algorithm.
• 7. The type of ground truth used: Not applicable in the context of device performance testing.
• 8. The sample size for the training set: Not applicable for a physical medical device.
• 9. How the ground truth for the training set was established: Not applicable for a physical medical device.

What the document does provide concerning "proving" the device:

The "proof" in this 510(k) submission comes from establishing substantial equivalence to an already legally marketed predicate device (K831647 Dentsply).

The key statements supporting this are:

• "The Bredent product is similar to the P.D. in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility characteristics as well as sizes and configurations. Therefore the Bredent product can be deemed substantially equivalent and effective for its indicated use."
• "The presented data that was conducted on the Bredent products shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any questions regarding safety and effectiveness." (However, the details of this data are not provided in this summary.)
• "All models that are covered by this 510(k) premarket notification have been on the market in Europe for many years with no device failures."
• "The used materials are well researched and do not raise any kind of question regarding safety and effectiveness of the finished product."

Essentially, the acceptance criteria are based on meeting the established safety and effectiveness profile of the predicate device, demonstrated through a comparison of technical characteristics and existing market experience. No specific performance study with defined quantitative acceptance criteria is detailed in this 510(k) summary.

Ask a specific question about this device

Bre.comp is intended to restore carious lesions or structural defects in teeth.

Bre.comp dentine/enamel/transparent is a light curing microhybride for anterior and posterior restorations. Bre.comp is based on BIS-GMA resins and inorganic fillers with particle size of 0.05 to 0.09 µm. The total filler content is 81% (weight percent) and 63% (volume percent). The composite material complies with the requirements of DIN EN ISO 4049.

Application range:
Universal dental restorative material for the following indications:

• cavity classes I to V
• inlays, veneers (direct and indirect)
• crown suprastructures
• post and core buildups

This document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. It is a 510(k) Summary for a dental restorative material (Bre.comp) and the FDA's clearance letter.

The document states:

• "The presented data that was conducts shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any questions regarding sofety and effectiveness." (Page 2)
• It also mentions compliance with DIN EN ISO 4049, which is a standard for dental polymer-based restorative materials.

However, it does not provide details on:

1. A specific table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any performance studies.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone performance studies with specific metrics.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on establishing substantial equivalence to a predicate device (K790439 - Vivadent (USA) Inc.) based on technical characteristics, indications for use, and general safety and effectiveness claims, rather than detailing a specific performance study with acceptance criteria.

Ask a specific question about this device

Bredent Breformance is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

breformance ColdCuringPolymer is a C+B material for temporary restorations

This document is a 510(k) summary for the Bredent Breformance temporary crown and bridge resin. It does not contain any information regarding acceptance criteria, device performance tables, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies.

The document states that:

• The Bredent product is similar to a predicate device (K013869 - Ivoclar Vivadent, Inc.) in terms of technical characteristics, design, indications for use, target population, where it is used, performance, biocompatibility, and sizes/configurations.
• The presented data (which is not included in the provided text) shows that the products are "absolutely safe and effective for their intended use."
• All models have been on the market in Europe for many years "with no device failures."
• The materials used are "well researched and do not raise any kind of question regarding safety and effectiveness of the finished product."

Therefore, based solely on the provided text, I cannot describe the acceptance criteria or the study that proves the device meets them because that information is not present. The submission relies on substantial equivalence to a predicate device and anecdotal evidence of market history in Europe.

Ask a specific question about this device