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ProLink: Direct Composite or Compomer restorations, Adhesive cementation, Composite repair. ProLink SE: Bonding of composites to tooth structure, Core Build up, Adhesive cementation of crown & bridges, including inlays and onlays.

ProLink is a 5th generation dentin/enamel single step bonding agent. The primer and adhesive are combined into a single component for ease of application. ProLink delivers outstanding shear bonding values to dentin, enamel & all popular light, dual or auto-cure composites. ProLink SE is a 7th generation light cured self etching dentin/enamel bonding agent. The etch, primer and adhesive are combined into a single component for ease of application. Separate conditioning (etching) of the enamel and dentine is not required.

The provided text describes the performance characteristics of the ProLink adhesives (ProLink, ProLink SE) and compares them to predicate devices. However, it does not include a table of acceptance criteria with specific numerical targets, nor does it detail a study that proves the device meets specific numerical acceptance criteria. Instead, it focuses on substantial equivalence to predicate devices based on general performance characteristics and physical tests.

Here's a breakdown of the information that is present and what is missing:

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

• Acceptance Criteria: Not explicitly stated as numerical targets. The document lists general performance characteristics expected from the device: "high bond strength," "a thin film thickness," "shelf stability," and "post placement stability." It does not provide threshold values for these characteristics.
• Reported Device Performance: No specific numerical performance values are reported for ProLink adhesives or the predicate devices. The study performed is described as "bench testing to evaluate the performance of the ProLink adhesives (ProLink, ProLink SE) compared to the following predicate devices." This implies a comparative study, but the results (e.g., specific shear bond strength values) are not included in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) The document mentions "bench testing" but does not specify the sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective.

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) This information is not applicable and hence not provided as the study involves bench testing of material properties, not human interpretation of medical images or diagnoses.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set This information is not applicable and hence not provided as the study involves bench testing of material properties, not human interpretation of medical images or diagnoses.

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 information is not applicable and hence not provided as the study involves bench testing of material properties, not human interpretation of medical images or diagnoses or AI systems.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done This information is not applicable and hence not provided as the study involves bench testing of material properties, not AI or algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth is established by the bench test measurements themselves (e.g., shear bond strength, marginal integrity). This is a direct measurement of the material's physical properties.

8. The sample size for the training set This information is not applicable and hence not provided as there is no mention of a "training set" as this is not an AI/machine learning study.

9. How the ground truth for the training set was established This information is not applicable and hence not provided as there is no mention of a "training set" or AI/machine learning.

Summary of the Study Mentioned:

• Study Type: Bench testing.
• Purpose: To evaluate the performance of ProLink adhesives (ProLink, ProLink SE) compared to four predicate devices: Adper Single Bond Plus, iBond Total Etch, G-Bond, and Clearfil Tri-S Bond.
• Properties Evaluated:
  • Shear Bond strength to etched enamel and to etched dentin
  • Marginal integrity
• Conclusion: The submission concludes that ProLink Adhesives are "safe and effective and substantially equivalent to the predicate devices described herein" based on intended use, indications for use, composition, physical properties, and technological characteristics. The results of the bench testing (e.g., specific bond strength values) are not reported in this summary, only that such tests were conducted for comparison to predicate devices. The basis for equivalence relies on similar technological characteristics (e.g., photoinitiator system, resin matrix, fillers, hybrid zone formation, hydrophilicity) and the assumption that if the technological characteristics are similar and the performance tests were conducted, then the new device performs comparably to the legally marketed predicates.

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ProFil: Direct anterior & posterior restorations, Core Build ups, Splinting. ProFil Flow: Class III, V & smaller Class IV restorations, Base/liner in Class I & Class II restorations, Repair resin, porcelain & acrylic temporary materials, Pit & fissure sealant, Undercut blockout, Restoration of minimally invasive cavity preparations.

The ProFil Composites are light cured restorative micro hybrid composite resins for use in both posterior and anterior restorations. The restoratives are available in a variety of tooth colored shades and are packaged in syringes and capsules.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a dedicated table format with corresponding reported performance values. Instead, it describes a "Summary of Physical Tests" and then presents a "Similarity of Technological properties to predicate devices" table to establish substantial equivalence.

However, based on the context, the implicit acceptance criteria for the ProFil Composites are that their physical properties and technological characteristics are comparable to or within acceptable ranges of the predicate devices.

Implicit Acceptance Criteria and Reported Device Performance (as inferred from the document):

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

The document mentions "data from bench testing" but does not provide specific details on the sample sizes used for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these bench tests.

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

This information is not applicable and not provided in the document. The study described is bench testing of material properties, not a clinical study requiring expert assessment of outcomes or images for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. As stated above, this was bench testing of material properties, not a study involving human readers or clinical outcomes requiring adjudication.

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 information is not applicable and not provided in the document. The device in question is a dental composite material, not an AI-powered diagnostic or assistive device for human readers.

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

This information is not applicable and not provided in the document. The device is a dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests would be the measured physical and chemical properties of the materials themselves, determined by standardized laboratory methods, and then compared to the established properties of the predicate devices. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

This information is not applicable and not provided in the document, as there is no training set mentioned or implied.

Summary of the Study Proving Substantial Equivalence:

The study proving the device meets its implicit acceptance criteria is a series of bench tests that evaluated various physical properties of the ProFil Composites (Compressive Strength, Flexural Strength, Surface Hardness, Water sorption, Polymerization shrinkage, Diametral Tensile Strength, Flexural Modulus, Radiopacity, Water solubility). The results of these bench tests were compared to those of three predicate devices: GrandiO, Unifil Flow, and Filtek Supreme Ultra Flowable.

The document emphasizes that "the information provided in this 510(k) submission shows that the ProFil Composites are substantially equivalent" to the predicate devices in terms of intended use, indications for use, composition, physical properties, and technological characteristics. The table comparing technological properties (Table 2) highlights the shared components and mechanisms (e.g., photoinitiator system, resin matrix type, silane-treated fillers, bonding method, polymerization process) as a key part of establishing this equivalence. The prior use of these components in legally marketed predicate devices is cited to support the safety and effectiveness without requiring additional biocompatibility testing of the final formulation.

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ProGlass One: Cementation of all types of metal, porcelain fused to metal, resin crowns, inlays, onlays & bridges; Cementation of orthodontic bands; Cementation of stainless steel crowns or orthodontic appliances retained with stainless steel crowns; Base/liner
ProGlass Two: Class III, V and limited class I cavities; Restoration of primary teeth; Core Build Up
ProGlass Two LC: Class III and V restorations; Restoration of Cervical erosions and root surface caries; Core Build Up; Base/Liner
ProGlass Nine: Class I & II cavities; Decidious teeth: final restorative for Class I, II and V; Long term restorative in non-load bearing areas of Class I, II and V; Intermediate restorative & sandwich material for heavy stress bearing; Core build up material
ProGlass Plus: Metal-based restorations; Ceramic inlays; Reinforced ceramic crowns and bridges; All kinds of acrylic/resin crowns, inlays, onlays and bridges
ProGlass Silver: Class I, limited Class II, temporary fillings; Restoration of primary teeth; Core Build Up; Base/Liner

The ProGlass cements are classified as a Dental Cement (21 C.F.R. part 872.3275) because they are devices composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

The provided document is a 510(k) summary for Silmet Ltd.'s ProGlass Cements. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, many of the requested categories cannot be fully addressed as a formal study with a test set, ground truth experts, and statistical comparisons was not conducted. The submission relies on the established safety and effectiveness of the predicate devices and the components used.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) submission does not detail specific quantitative acceptance criteria for performance metrics (beyond general physical characteristics) that the device must meet, nor does it present a study explicitly comparing the new device's performance against such criteria.

The document includes a table of "Physical characteristics" (Table 2 on page 1) which lists:

• Powder/liquid ratios
• Mixing time
• Working time
• Setting time
• Light Cure time (for ProGlass Two LC)

However, these are presented as characteristics of the ProGlass Cements, not as performance targets or acceptance criteria with corresponding results from a study designed to prove them. The stated acceptable ranges are implicitly derived from the properties of the predicate devices.

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

• Sample Size: Not applicable. No dedicated "test set" in the context of a clinical performance study is described. The submission primarily relies on the well-established properties of the components and the predicate devices.
• Data Provenance: Not applicable.

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

• Not applicable. As no clinical performance study with a test set requiring expert ground truth was conducted, this information is not provided.

4. Adjudication Method 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 submission for dental cements, not an AI or imaging device, so an MRMC study is irrelevant.

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

• Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is effectively the established safety and effectiveness of the predicate devices and the individual components, supported by their long history of clinical use.

8. The Sample Size for the Training Set

• Not applicable. There is no training set in the context of an algorithm or AI development.

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

• Not applicable.

Summary of the Study that Proves the Device Meets the Acceptance Criteria (Based on the document):

The "study" described in this 510(k) submission is primarily a comparison to predicate devices and a demonstration of component safety and technological equivalence, rather than an independent clinical performance study with explicit acceptance criteria.

• Basis of Proof: Silmet Ltd. asserts that ProGlass Cements are safe and effective because:

  • All components used in ProGlass Cements are found in legally marketed predicate devices (Fuji I, Fuji II, Fuji II LC, Fuji IX, Fuji Plus, Miracle Mix – all by GC America).
  • The material, design, and use concept of ProGlass Cements are similar to these predicate devices.
  • The prior use of these components in legally marketed devices and the performance data of those devices support the safety and effectiveness of ProGlass Cements, making additional testing for cytotoxicity, mutagenicity, or other biocompatibility studies unnecessary.

• Conclusion: Based on this comparison and component analysis, Silmet Ltd. concludes that ProGlass Cements are substantially equivalent to the predicate devices, thereby meeting the implicit "acceptance criteria" of being as safe and effective as existing legally marketed devices.

This approach is common for Class II medical devices seeking 510(k) clearance, where substantial equivalence to a predicate device eliminates the need for extensive de novo clinical trials unless significant technological differences or new safety/effectiveness questions arise.

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