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Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.

Preformed denture teeth used for total and partial dentures and implant-supported removable prostheses.

The provided 510(k) summary describes a device, SR Vivodent S, SR Orthotyp S, SR Ortholingual S, which are preformed denture teeth. This notification is for a dental device, not an AI/ML powered medical device. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, training set size) are not applicable to this type of device submission.

The submission focuses on demonstrating substantial equivalence to predicate devices (SR Vivodent PE, SR Orthotyp PE, and Phonares II) through material composition, performance data, and indications for use.

Here's the information that can be extracted from the provided text according to your request:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for this type of device. The submission references compliance with international standards for material properties and performance rather than clinical test sets with specified sample sizes or data provenance. The testing would have been conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth in the context of AI/ML or diagnostic devices is not relevant here. The "ground truth" for this device is its adherence to established material and performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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 a physical dental device, not an AI-assisted diagnostic tool.

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

• Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance is compliance with international standards (ISO 22112:2005, ISO 10477:2004, DIN EN ISO 2039-1, ISO 10993) for material properties and physical performance.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

• Not applicable.

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These dental plastic teeth are parts used for denture fabrication. PMMA is mixed with monomer in a polymenzation process. The plastic teeth are part of dentures made to fit a patient's mouth which are removable or may be attached to dental implant devices.

The synthetic plastic teeth are used in the production of dentures. They are produced from a I he synuletic process. Polymethylmethacrylate or PMMA is mixed with methylmethacrylate monomer, a cross linking agent and non-toxic pigments under heat and pressure. Once the monomer, a cross iniking agoit and non teen are checked for flash and polished according to the relevant model characteristics.

The provided text is a 510(k) summary for "Denture Preformed Plastic Teeth Proprietary Models: Dentavit, Monarch, Acrotone, Senator, Dentorium". This document is a premarket notification to the FDA for medical devices.

Crucially, this document describes a device that is a physical product (plastic teeth for dentures), not an AI/ML powered device, a diagnostic device, or a software device that would require performance criteria in the way your request outlines.

Therefore, the requested information about acceptance criteria, study details, sample sizes, experts, MRMC studies, standalone performance, and ground truth types is not applicable to this document.

The 510(k) summary focuses on demonstrating Substantial Equivalence to legally marketed predicate devices, meaning it argues that the new device is as safe and effective as existing, approved devices.

Here's a breakdown of what the document does provide, related to its safety and effectiveness, in the context of substantial equivalence:

1. Acceptance Criteria and Reported Device Performance (as applied to Substantial Equivalence):

Instead of performance metrics like sensitivity, specificity, or AUC for an AI device, this document demonstrates equivalence through material composition, manufacturing process, and adherence to established standards.

• ISO9001/GMP/ISO13485: Quality System Certification
• ADA specification No. 15:2008 Artificial Teeth
• BS EN ISO22112:2006
• Biocompatibility Standards ISO10993-1, ISO7405:2008 |
  | Lack of New Safety/Effectiveness Questions | "This control activity shows that there are no new questions of safety and effectiveness for the plastic teeth models made by Wright." "The minor differences raise no new issues of safety or effectiveness." |
  | Company History/Experience | "Wright has been a manufacturer for about 100 years and has been in the market for over 40 years and has met preamendment rules. There are no significant health incidents in that time." |

The following points cannot be answered from the provided text as they relate to AI/ML or diagnostic device studies, which is not what this document describes:

2. Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML algorithm evaluation. The "testing" referred to is physical materials reliability and safety testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the AI/ML sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. There is no AI/ML model with a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary: This 510(k) pertains to denture teeth, a traditional medical device, not a software or AI-powered one. Therefore, the typical performance criteria and study design elements for AI/ML devices or diagnostics as requested are not present in this submission. The "study" proving acceptance criteria is a compilation of material testing, adherence to manufacturing quality standards, and comparison to predicate devices, all aimed at demonstrating substantial equivalence.

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A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.

The New Stetic Acrylic Teeth are made of acrylic resin; the teeth come in various shades and sizes to fit the requirements of the specific patient.

The provided text details the 510(k) summary for the New Stetic Artificial Teeth, which is a preformed plastic denture tooth. The submission asserts substantial equivalence to a predicate device (King Dental Corp - King-Hue, Royal Coral, Super-C Artificial Teeth, K931162).

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The device, New Stetic Artificial Teeth, is a Class II device (Preformed Plastic Denture Tooth) with product code ELM. The performance testing was conducted according to ISO 22112 First edition 2005-11-01, Dentistry -- Artificial teeth for dental prostheses.

The text does not explicitly list specific numerical acceptance criteria (e.g., minimum flexural strength, maximum water absorption) or reported device performance values in a table format. Instead, it states that "Performance testing was completed to ISO 22112 First edition 2005-11-01." This implies that the device met all the requirements outlined in this international standard for artificial dental prostheses.

Without specific performance values from the standard or the study, a "reported device performance" column cannot be fully populated with numerical data. However, based on the FDA's clearance, it is understood that the device did meet all applicable criteria within ISO 22112.

*Note: The 510(k) summary does not reproduce the detailed specifications of ISO 22112. These would typically include tests for properties like bond strength, color stability, water sorption, solubility, hardness, and mechanical strength relevant to dental prostheses.

Study Information

1. Sample sizes used for the test set and the data provenance:
   The document does not specify the sample size used for the test set during performance testing. It also does not mention the country of origin of the data or whether the study was retrospective or prospective. The testing was conducted to an international standard (ISO 22112), which dictates testing methodologies but not necessarily data provenance in this context.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the 510(k) summary. Given that the testing was based on a laboratory standard (ISO 22112) for physical and material properties, the "ground truth" would be established through calibrated laboratory instruments and adherence to testing protocols, rather than expert human interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable or provided. Laboratory-based performance testing following an ISO standard typically relies on objective measurements rather than human adjudication of results in the way clinical studies might.

4. 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:
   No MRMC study was done. This device is a preformed plastic denture tooth, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. The assessment focuses on the material and physical properties of the teeth.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This device is a physical product (artificial teeth), not an algorithm or software. Its performance is inherent in its material properties and manufacturing.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth for this type of device is established by objective measurements of material properties and performance characteristics defined by the international standard ISO 22112. This standard specifies tests for things like flexural strength, water absorption, color stability, and bond strength as relevant to artificial teeth. There is no "pathology" or "outcomes data" in the clinical sense for this type of premarket submission, as it relates to the physical product itself.

7. The sample size for the training set:
   Not applicable. This device is a physical product, not a machine learning algorithm, so there is no "training set."

8. How the ground truth for the training set was established:
   Not applicable. As there is no training set for a physical product, this question is not relevant.

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Physiostar NFC denture teeth are intended to be used for complete and partial denture r nyslostar NF & dontare tooling and implant-supported dentures.

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I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to Candulor USA, Incorporated, regarding their Physiostar NFC device, which is a preformed plastic denture tooth.

The letter confirms the FDA's determination of substantial equivalence for the device based on its intended use, but it does not detail any performance studies, acceptance criteria, or specific performance metrics of the device itself. It mainly focuses on regulatory aspects and compliance requirements.

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Used as artificial teeth to produce partial and full dentures.

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This document is a 510(k) premarket notification approval letter for a dental device, "Veracia." It confirms the device's substantial equivalence to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving the device meets those criteria. It is an approval letter, not a device performance report.

Therefore, I cannot provide the requested information based on the provided text.

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Artegral HD are posterior preformed plastic denture teeth for use in:

• supra construction for combined, fixed removable dental prostheses .
• hybrid construction for implant-supported dental prostheses .
• cover denture .
• total prostheses .
• model cast prostheses ●
• . partial dentures

artegral HD are preformed posterior plastic teeth made from an Interpenetrated Network (IPN) of polymethylmethacrylate (PMMA) with two finer Networks. The tooth neck is made from Organic Modified Polymer Network (OMP-N) and the incisal and dentine portions of the tooth are made from Highly Modified Polymer-Network (HMP-N). OMP-N has added insoluble PMMA spheres, and HMP-N has added amorphous silicon dioxide nanoparticles and fluorapatite. The artegral HD teeth comply with all the requirement of ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses. The additives in artegral HD teeth are known biocompatible materials.

The provided document, K120404, pertains to the 510(k) premarket notification for the Merz Dental GmbH artegral HD preformed plastic denture teeth. This submission focuses on chemical and physical characteristic comparisons to a predicate device, rather than a diagnostic AI device requiring performance metrics like sensitivity or specificity. Therefore, many of the requested categories related to AI device performance evaluation are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• The document does not specify a "test set" in the context of diagnostic data. The testing involved samples of the artegral HD teeth and their material components.
• Data Provenance: The tests were conducted internally by Merz Dental GmbH (Germany). The specific labs or testing facilities are not detailed, but the document refers to compliance with international standards (ISO, USP, EC, OECD, EN/DIN), implying standard testing methodologies. All testing was prospective, as it was performed on the device components for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is not a diagnostic tool requiring expert interpretation of images or clinical data to establish ground truth. The "ground truth" here is compliance with established physical, chemical, and biological standards.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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 device is not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is not an algorithm. Performance testing was done on the physical product and its constituent materials.

7. The type of ground truth used:

• Standard-based compliance: The ground truth for this device is based on the requirements and limits defined in established international and national standards for artificial denture teeth and biocompatibility, such as:
  • ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses
  • ISO/CD 20795-1 "Dentistry - Base polymers - Part 1: Denture base polymers"
  • USP 29 (United States Pharmacopeia)
  • ISO 10993 Part 5 (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)
  • EC method B.6. (European Commission method)
  • OECD guideline 406 (OECD Guidelines for the Testing of Chemicals - Skin Sensitisation)
  • EN/ISO/DIN 10993-10.2 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)

8. The sample size for the training set:

• Not applicable. This device does not use machine learning, so there is no training set.

9. How the ground truth for the training set was established:

• Not applicable. See point 8.

In summary: The K120404 submission for Merz Dental GmbH artegral HD preformed plastic denture teeth is primarily a substantial equivalence claim based on demonstrating that the device meets the physical, chemical, and biological safety requirements of relevant international standards. It does not involve AI or diagnostic performance studies that would utilize concepts like ground truth established by experts, test sets, or training sets. The "proof" that the device meets acceptance criteria comes from the successful completion of the specified laboratory tests according to the cited standards.

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SR Phonares II denture teeth are intended to be used for complete and partial denture prosthetics including hybrid dentures and implant-supported dentures.

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I am sorry, but based on the provided text, there is no information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The provided text is an FDA 510(k) clearance letter for a device called "SR PHONARES® II," which is a "Plastic Denture Tooth." This document only states that the device is "substantially equivalent" to legally marketed predicate devices and outlines general regulatory compliance information. It does not contain any technical performance data, study results, or specific acceptance criteria.

To answer your request, I would need a document that describes the device's technical specifications, performance goals, and the results of a study designed to demonstrate those goals were met.

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Used as artificial teeth to produce partial and full dentures.

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The provided document is a 510(k) premarket notification letter from the FDA for a dental device called "Veracia SA," which is described as a preformed plastic denture tooth.

This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it pertains to AI/algorithm performance. It is a regulatory approval for a physical dental product, not a software or AI-powered medical device.

Therefore, I cannot provide the requested information for an AI/algorithm-based device from this document.

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The bredent novo.lign A / novo.lign P are preformed plastic denture teeth as a prefabricated device, composed of materials such as polymethylmethacrylat and methylmethacrylat that are intended for use as veneers. The bredent novo:lign P are used for temporary or partial or full dentures.

Permanent veneering:

• telescopic and conical crowns
• CoCr clasp restorations
• crowns and bridges
• implant-supported restorations
• coverdenture techniques

Veneer-up:

• selection of esthetic shade, shape and tooth position

Temporary restorations:

• laboratory-made temporaries based on impression and wax-up
• veneer on temporary abutments after placement of the implant
  The devices are offered in non-sterile condition.

Bredent novo.lign A / novo.lign P artificial are multi-layer veneers for anterior and posterior teeth. Theses teeth devices are chemically based on polymethacrylate-polymers and their chemical properties. These reformed plastic dentures are used when fabricating any kind of dental restauration (see application range beneath).

The provided text describes a 510(k) premarket notification for "bredent novo.lign A / novo.lign P" artificial teeth, which are preformed plastic denture teeth. The submission aims to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical acceptance criteria or specific performance metrics as typically seen for AI device evaluations (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating equivalence to a predicate device through compliance with recognized standards and a summary statement of similar performance.

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

The document does not describe a traditional "test set" or a study involving patient data in the context of AI/diagnostic device evaluation. The evaluation appears to be based on adherence to standards for material properties and biocompatibility.

• Sample Size: Not applicable in the context of an AI-like test set. The material testing would involve specific quantities of the artificial teeth but these are not disclosed as "sample sizes" for a clinical study.
• Data Provenance: Not applicable for a traditional test set. The compliance tests would have been performed in a laboratory setting. No country of origin for specific "data" or whether it's retrospective/prospective is mentioned for a clinical evaluation.

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

This information is not applicable. The device is a physical product (artificial teeth) and the evaluation is based on engineering and material standards, not diagnostic interpretation by experts. There is no concept of "ground truth" established by experts in the way an AI diagnostic algorithm would require.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" requiring expert adjudication for this type of device.

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 diagnostic device. No human-in-the-loop study, MRMC study, or AI assistance is mentioned.

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

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used:

Not applicable in the context of AI evaluation. The "ground truth" for this product would be the established scientific and engineering specifications and performance requirements defined in the referenced ISO and ADA/ANSI standards for implantable/dental materials.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this device.

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It is intended for use as a tooth in a denture.

These teeth are used for making full or partial dentures. The artificial resin teeth are mounted on an appliance made of dental acrylic resin. The appliance is made to fit the patient's mouth and is a removable. It is not implanted.

The Synthetic Polymer Teeth (Kaifeng/Crystal, Kaili, Kaijing, Kaiyue, MAIST and Kaitong/Royal) used in the production of dentures are produced through a dough molding process. Polymethylmethacrylate (PMMA) is mixed with methylmethacrylate monomer and a crosslinking agent.

Once the polymerization process has been carried out, the teeth are obtained and the next step is to remove any burrs and polish them.

The provided text describes a 510(k) premarket notification for "SYNTHETIC POLYMER TEETH". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies.

Therefore, the document explicitly states:

• "Discussion of Clinical Tests Performed: None"

This means there was no clinical study conducted to establish performance and acceptance criteria for the device itself. Instead, the submission relies on the established safety and effectiveness of the predicate devices and the new device's material and manufacturing similarity to them.

As a result, I cannot provide the requested information in the format of acceptance criteria and reported device performance based on a study, as such a study was not performed as part of this 510(k) submission.

To answer your request based on the provided document, here's what can be extracted:

No Clinical Study Performed for this Device

The submission explicitly states that no clinical tests were performed to establish performance or meet specific acceptance criteria for the SYNTHETIC POLYMER TEETH.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. No acceptance criteria were defined or measured through a clinical study for this device as part of the 510(k) submission. The submission relies on establishing substantial equivalence to predicate devices through non-clinical bench and biocompatibility testing.

2. Sample size used for the test set and the data provenance

Not applicable. No clinical test set was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set and thus no ground truth established by experts for a test set.

4. Adjudication method for the test set

Not applicable. No clinical test set.

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 device is a preformed plastic denture tooth, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

Not applicable. This device is a preformed plastic denture tooth, not an algorithm.

7. The type of ground truth used

Not applicable. No clinical study was performed requiring ground truth.

8. The sample size for the training set

Not applicable. No machine learning model was developed for this device.

9. How the ground truth for the training set was established

Not applicable. No machine learning model was developed for this device.

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