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Etching the enamel and dentine for adhesive restorations.

DenFil™ Etchant-37 is an etching agent consists of 37% phosphoric acid formulations thickened with natural polymer. It is classified into tooth shade resin material, 21 CFFR Section 872.3690, because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration.

The provided text describes a 510(k) submission for a dental etching agent, DenFil™ Etchant-37, and focuses on demonstrating its substantial equivalence to a predicate device, K-ETCHANT GEL. This type of submission does not typically involve a clinical study with detailed acceptance criteria and performance metrics in the way a novel device might. Instead, the focus is on showing similarity to an already approved device.

Here's an analysis based on the provided information, noting where specific details are absent due to the nature of a 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a comparison study demonstrating substantial equivalence to the predicate device, K-ETCHANT GEL (K062409).

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

• Test Set Sample Size: Not applicable in the context of a clinical trial with human subjects for performance evaluation as described. The "test set" here refers to samples of the etching agent itself (DenFil™ Etchant-37) used for characterization and comparison to the predicate device. The specific number of samples for pH, adhesion, and viscosity testing is not provided in this summary.
• Data Provenance: The tests (physical property measurements, biocompatibility) would have been performed by Vericom Co. Ltd. or its contracted labs. The data would be prospective in the sense that DenFil™ Etchant-37 was manufactured and then tested. The country of origin for the testing itself is likely South Korea, where Vericom Co. Ltd. is based.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. For a dental etching agent seeking 510(k) clearance based on substantial equivalence, "ground truth" isn't established by expert consensus on clinical outcomes in the same way it would be for a diagnostic AI device. Instead, the "truth" is based on established scientific principles for chemical composition, physical properties, and safety standards for dental materials.
• Qualifications of Experts: Not specified. Any experts involved would be material scientists, chemists, or toxicologists assessing the properties and safety of the dental material.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no human interpretation of results requiring adjudication in this type of submission. The results of the physical and chemical tests are objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (e.g., medical imaging AI) to compare the performance of human readers with and without AI assistance. DenFil™ Etchant-37 is a dental material, not a diagnostic AI tool.

6. Standalone Performance Study (Algorithm Only)

• Standalone Study: No, a standalone performance study in the context of an "algorithm only" is not applicable as DenFil™ Etchant-37 is a chemical product, not a software algorithm. Its performance is evaluated through material science testing.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device is based on established scientific and engineering principles for dental materials. This includes:
  • Chemical composition standards: Ensuring the phosphoric acid concentration is 37% and the thickening agent is a natural polymer as specified.
  • Physical property measurements: Objective measurements of pH, adhesion strength to enamel/dentin, and viscosity.
  • Biocompatibility standards: Compliance with international and US regulations for materials that come in contact with human tissue.
  • Performance relative to a predicate device: The predicate device (K-ETCHANT GEL) serves as the benchmark for "acceptable" performance and safety.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. DenFil™ Etchant-37 is a manufactured chemical product, not a machine learning algorithm that requires a "training set" of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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• Class V restorations (cervical caries, root erosion, wedge shaped defects)
• Anterior restorations (Class III, IV)
• Small posterior restorations
• Restorative therapy for mini-cavities of all types
• Extended fissures sealings in molars and premolars
• Repair of composite/ceramic veneers
• Blocking out of undercuts

DenFil™ flow is a light-cured radio-opaque flowable restorative resin. It is composed of Epoxyacrylate(Bis-GMA), Diurethane dimethacrylate, Triethyleneglycol dimethacrylate, Barium aluminosilicate and other materials. As DenFil™ flow has a lower viscosity than paste type composite resin-Flow; 0.16 mm/30sec, so it can restore narrow & deep cavity easily. DenFil™ flow can be applied to fill cavities of all types exactly and efficiently by using a disposable tip. And DenFil™ flow has various shade that correspond to the most common used shading system.

The provided text is a 510(k) summary for a dental composite material called DenFil™ flow. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The 510(k) summary focuses on demonstrating substantial equivalence between DenFil™ flow and a predicate device (Tetric Flow, K993783) based on similar technological characteristics (main material, chemical composition, radiopacity, visible light activation, and design) and mechanical properties (compressive strength, flexural strength, flow, film thickness, wear, polymerization shrinkage, and thermal expansion coefficient). It also mentions that safety tests, including biocompatibility, were performed to ensure compliance with regulations.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study as requested because this information is not present in the provided document.

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DenFil™ is indicated for the following restorative applications;

1. Class: I, II, V restorations of posterior teeth
2. Class III, IV, V restorations of anterior teeth
3. Cervical cavities or defects involving root surfaces

DenFillM is light-cured restorative hybrid composite resin and accessories for use in both Posterior and Anterior restoration

This document is a 510(k) premarket notification for a dental composite material, DenFil™. It establishes substantial equivalence to existing predicate devices. However, it does not contain a study that proves the device meets specific acceptance criteria in the way modern AI/ML device submissions do.

Instead, the submission relies on the concept of substantial equivalence to predicate devices (Clearfil AP-X, Kuraray Medical Inc., K012740; Clearfil AP-X PLT, Kuraray Medical Inc., K023002; Multiple, Dentsply Intl., K863092). This means that the device is deemed safe and effective because it has the "same device characteristics as the predicate device" and its "material, design and use concept is similar."

Therefore, I cannot fill out the requested table and answer the study-specific questions as they do not apply to this type of submission.

Here's a breakdown of why and what information is available:

• Acceptance Criteria & Device Performance: Not applicable in the context of an AI/ML device and specific performance metrics. The implicit "acceptance criteria" is that it performs similarly enough to the predicate devices.
• Study That Proves the Device Meets Acceptance Criteria: No clinical study or performance study with defined acceptance criteria and statistical analysis is provided or required for this type of 510(k) submission. The document states:
  • "DenFil™ has been subjected to extensive safety, performance, and product validations prior to release."
  • "Safety tests have been performed to ensure the devices comply to applicable industry and US regulations."
  • "An extensive review of literature pertaining to the safety and biocompatibility of DenFil™ has been conducted."
    These are general statements about pre-market activities, not a specific study detailing results against acceptance criteria.
• Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth, training set: These concepts are relevant for AI/ML device submissions, which involve algorithms learning from data and then being tested. This 510(k) is for a physical medical device (dental composite) and therefore these questions do not apply.

In summary, this 510(k) submission for DenFil™ is based on establishing substantial equivalence to legally marketed predicate devices, not on a clinical or performance study that explicitly defines and measures quantifiable acceptance criteria for an AI/ML component.

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