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510(k) Data Aggregation
(60 days)
Fusion Bond 5 is indicated for direct composite or compomer restorations, adhesive cementation, and composite repair.
Fusion Bond 7 is indicated for bonding of composites to tooth structure, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.
Fusion Bond DC is indicated for direct light cure composite or compomer restorations, core build up, and adhesive cementation of crown & bridges, including inlays and onlays.
Renew MDP is indicated for bonding of dual cure, light cure or self cure composite or compomer restorations to tooth structure. treatment of hypersensitive teeth, and intraoral repairs of fractured restorations.
Renew Universal is indicated for direct bonding of light-cured compomers to tooth structure, bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured. intraoral repair of composite, metal-based and zirconia /alumina-based restorations, intraoral repair of ceramic restorations in combination with a silane coupling agent, treatment of hypersensitive teeth, and cavity sealing as a pretreatment for indirect restorations.
Prevest Denpro Tooth Bonding Agents attach different types of restorations to teeth.
Fusion Bond 5 is a light curing single component bonding agent. It primes and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures. Tooth structures should have a 37% phosphoric acid etchant application of Fusion Bond 5.
Fusion Bond 7 is a light curing single component bonding agent. It etches, primes, and bonds in one step to attach restorations of composites, copomers, amalgams, and porcelains to tooth structures.
Fusion Bond DC is a dual cure bonding direct and indirect restorations. Enamel and dentin surfaces should be conditioned with 37% phosphoric acid etchant before application of Fusion Bond DC. It is a two component adhesive with bonding agent and activator.
Renew MDP is a light curing single component bondines etching, priming and bonding in one bottle. It is an ethanol-water based dental adhesive containing 10-Methacryloyloxydececyl Dihydrogen Phosphate (10-MDP) a functional monomer which helps in bonding to dentin and cut and un-cut enamel. Renew MDP works with light-cured and dual-cured composite materials.
Renew Universal is a light curing single component bondines etching, priming and bonding. Renew Universal contains a combination of functional monomers such as 10-MDP and 4-META. Renew Universal works with light-cured and dual-cured composite materials.
This document describes a 510(k) premarket notification for a series of dental bonding agents manufactured by Prevest Denpro Limited. The purpose of the 510(k) is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical efficacy through a comparative effectiveness study with human readers and AI assistance. Therefore, many of the requested criteria often associated with AI/ML medical devices are not applicable to this submission.
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are established by the ISO 29022:2013 standard, specifically for "Dentistry - Adhesive - Notched-edge shear bond strength test." The reported device performance is stated as "Complies with ISO 29022" for both shear bond strength and curing time, with specific values provided as well.
| Device Name | Acceptance Criteria (from ISO 29022:2013) | Reported Device Performance (Shear Bond Strength) | Reported Device Performance (Curing Time) |
|---|---|---|---|
| Fusion Bond 5 | Complies with ISO 29022 (Shear Bond Strength) | 10 MPa | 20-30 sec |
| Complies with ISO 29022 (Curing Time) | |||
| Fusion Bond 7 | Complies with ISO 29022 (Shear Bond Strength) | 25 MPa | 20-30 sec |
| Complies with ISO 29022 (Curing Time) | |||
| Fusion Bond DC | Complies with ISO 29022 (Shear Bond Strength) | 19 MPa | 20-30 secs |
| Complies with ISO 29022 (Curing Time) | |||
| Renew MDP | Complies with ISO 29022 (Shear Bond Strength) | 21 MPa | 20-30 secs |
| Complies with ISO 29022 (Curing Time) | |||
| Renew Universal | Complies with ISO 29022 (Shear Bond Strength) | 21 MPa | 20-30 secs |
| Complies with ISO 29022 (Curing Time) |
Note: The document explicitly states "All test results met the criteria in standard." The specific numeric values (e.g., 10 MPa for Fusion Bond 5) are the reported performance, which is implicitly accepted as meeting the standard's criteria.
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 does not specify the exact sample sizes used for each test. It states "Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP and Renew Universal were tested for appearance, shear bond strength and curing time according to protocols based on ISO 29022:2013."
The data provenance is from Prevest Denpro Limited, located in Bari Brahmana, Jammu 181133 India. The tests are presented as part of a regulatory submission, implying they were prospective tests conducted specifically for this 510(k).
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 is a physical testing submission, not a diagnostic imaging AI/ML device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image interpretation (e.g., radiologists) is not applicable. The ground truth is established by the physical properties measured according to an international standard (ISO 29022:2013).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing consensus among human readers for image interpretation. This submission involves physical, objective measurements.
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
No, an MRMC comparative effectiveness study was not done. This is not an AI/ML medical device where human reader performance with and without AI assistance is relevant. This is a dental material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component in these dental bonding agents. The "performance" is the physical properties of the material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the device's performance is based on objective physical measurements conducted according to the ISO 29022:2013 standard for dental adhesives, specifically for shear bond strength and curing time. In essence, the ground truth is the scientific and engineering standard.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of machine learning for this type of device. The products are dental materials, and their formulation and manufacturing are based on established chemical and material science principles, not on iterative training data.
9. How the ground truth for the training set was established
Not applicable. As there is no training set (in the ML sense), there is no ground truth to establish for it. The "ground truth" for the development of these materials would stem from principles of chemistry, material science, and prior knowledge in dental adhesive development.
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(367 days)
- All classes of direct restoration with composites (class I, II, III, IV and V);
- Adhesive luting (in addition to resin cement) of prosthetic pieces (post/cores, crowns, onlays/inlays, veneers etc.) made of fiberglass, ceromer, ceramic, resin and metal;
- Adhesive repairs in ceramic and composites.
*Only for Ambar Universal APS: Use as metallic or ceramic primer.
Ambar APS is a light-curing 5th generation adhesive (two-step adhesive, total etch technique) for bonding restorative materials to dental tissue (enamel and/ or dentin). As the primer and the bonding agent are combined in a single bottle, acid etching is the only previous step needed before applying the adhesive to dentin and enamel.
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. The primer and bonding agent are combined in a single flask. Prior use of acid etchant is optional on both tooth 's enamel and dentin, it can be used, therefore, in three ways: self-etch, selective-etch and total-etch.
This document, a 510(k) premarket notification from the FDA, describes DentsCare LTDA's dental bonding agents (Ambar APS and Ambar Universal APS) and their substantial equivalence to predicate devices. The listed information pertains to the non-clinical testing conducted to demonstrate the device's performance characteristics, not a human-in-the-loop AI study. Therefore, sections related to multi-reader multi-case (MRMC) comparative effectiveness, number of experts for ground truth, adjudication methods, or training set details are not applicable here.
The study proves the device meets acceptance criteria through a series of physical and chemical tests comparing the subject devices to internationally recognized commercial adhesives (predicates).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are explicitly stated as "if the adhesive under study has a mean $\ge$ than the competing adhesives analyzed," or similar comparative statements.
| Test | Acceptance Criteria | Reported Device Performance (Ambar APS ± SD) | Reported Device Performance (Ambar Universal APS ± SD) | Performance of Predicate Devices (Range or Avg ± SD) |
|---|---|---|---|---|
| Adhesive Strength (MPa) | Mean $\ge$ competing adhesives | $38.61 \pm 1.68$ | $38.02 \pm 3.33$ | $26.20 \pm 2.19$ (Single Bond 2), $34.47 \pm 3.34$ (Single Bond Universal), $33.27 \pm 3.91$ (Tetric - N - Bond Universal) |
| Degree of Conversion (GC) | Mean $\ge$ competing adhesives | $53.8 \pm 0.5$ | $55.80 \pm 0.5$ | $43.5 \pm 1.3$ (Single Bond 2), $55.60 \pm 0.5$ (Single Bond Universal), $45.07 \pm 0.6$ (Tetric - N - Bond Universal) |
| Shear Bond Strength (MPa) (ISO 29022:2013) | Mean $\ge$ competing adhesives (ISO 29022 does not quantify acceptable values, so comparison to recognized brands is used) | $22.21 \pm 2.33$ | $16.30 \pm 1.67$ | $20.06 \pm 2.52$ (Single Bond 2), $16.97 \pm 1.83$ (Single Bond Universal), $11.91 \pm 1.39$ (Tetric - N - Bond Universal) |
| pH | Low hydrogen potential as competing adhesives (comparative analysis) | $3.16 \pm 0.02$ | $2.97 \pm 0.04$ | $4.69 \pm 0.03$ (Single Bond 2), $3.28 \pm 0.19$ (Single Bond Universal) |
| Viscosity (mPa.s) | In accordance with desired application (based on market absence of claims) | $81.33 \pm 2.05$ | $99.20 \pm 0.40$ | Not performed for predicate devices (not contemplated in regulations) |
| Water Sorption ($\mu g/mm^3$) | Better or statistically equal to competitors | $140.80 \pm 1.60$ | $145.53 \pm 3.12$ | $150.76 \pm 2.26$ (Single Bond 2), $148.38 \pm 2.28$ (Single Bond Universal) |
| Water Solubility ($\mu g/mm^3$) | Better or statistically equal to competitors | $64.61 \pm 1.86$ | $64.71 \pm 1.59$ | $63.29 \pm 2.59$ (Single Bond 2), $71.24 \pm 5.54$ (Single Bond Universal) |
| Accelerated Stability Studies | Product maintains characteristics for estimated shelf life | Ambar APS: Shelf life estimated at 3 years ($30^\circ C$) | Ambar Universal APS: Shelf life estimated at 2 years ($25^\circ C$) | Not applicable (Individual product stability) |
| Long-Term Stability Evaluation | Confirms expiration date and storage conditions | Ambar APS: 3 years at $30^\circ C$ confirmed | Ambar Universal APS: 2 years at $30^\circ C$ confirmed | Not applicable (Individual product stability) |
| Transport Evaluation | Product maintains characteristics during transport | Product can be transported between $50^\circ C$ and $-5^\circ C$ | Product can be transported between $50^\circ C$ and $-5^\circ C$ | Not applicable (Individual product transport) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of specimens tested) for each physical/chemical test. It presents mean values with standard deviations, which implies multiple measurements were taken for each test. The data provenance is not specified beyond being "non-clinical testing" and conducted for a Brazilian manufacturer (DentsCare LTDA). It is implicitly a prospective evaluation of newly manufactured devices under controlled laboratory conditions, not retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The "ground truth" for this type of non-clinical testing is established by physical and chemical measurements (e.g., MPa for strength, pH values) performed in a laboratory setting, not by human expert interpretation of images or clinical outcomes.
4. Adjudication Method for the Test Set
This section is not applicable, as the data collection involves objective physical/chemical measurements, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This document describes non-clinical laboratory testing of dental bonding agents, not an AI-assisted diagnostic device evaluated with human readers.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Yes, in a sense, the performance described here is "standalone" to the device itself (the bonding agent) and its inherent physical/chemical properties, rather than its interaction with a human user or an AI algorithm. The performance metrics are intrinsic to the material.
7. The Type of Ground Truth Used
The ground truth used for these tests is objective, quantitative physical and chemical measurements obtained through laboratory testing, such as:
- Adhesive Strength: Measured in Megapascals (MPa).
- Conversion Rate: Percentage of monomer converted to polymer.
- Shear Bond Strength: Measured in Megapascals (MPa).
- pH: pH value.
- Viscosity: Measured in milliPascal-seconds (mPa.s).
- Water Sorption/Solubility: Measured in micrograms per cubic millimeter ($\mu g/mm^3$).
- Stability: Duration under specific temperature conditions.
8. The Sample Size for the Training Set
This section is not applicable. This is not an AI/machine learning study, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable, as there is no training set for this type of non-clinical device testing.
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