(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.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.