Novidia Universal Bond

• K Number: K183391
• Device Name: Novidia Universal Bond
• Manufacturer: Nobio Ltd.
• Date Cleared: 2019-09-24 ( 291 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K920424 , K942493 , K023842 , K033938

Intended Use

Novidia Universal Bond is indicated for:

• 1. Direct restorations using light-cured composite resin or compomer
• 2. Cavity sealing as a pretreatment for indirect restorations
• 3. Treatment of hypersensitive teeth and/or exposed root surfaces
• 4. Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin
• 5. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin
• 6. Core build-ups using light- or dual-cured composite resin
• 7. Cavity sealing under amalgam restorations

• For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.

Device Description

Novidia™ Universal Bond is a resin-based bond system consisting of a self-etch primer and a light-cured bond. It is designed to enhance penetration into prepared enamel and dentin surfaces and to establish strong adhesion between mineralized dental surfaces and the restorative materials such as resin composites, resin cements, metals, and ceramics (e.g., porcelain, lithium disilicate, zirconia, or hybrid ceramics) restorations. The chemical composition of the Universal Bond's primer consists of adhesion promoter and solvent, and the Universal Bond consists of resin, solvent, initiators and antibacterial insoluble particles, which contain covalently bound quaternary ammonium (QA).

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Novidia™ Universal Bond, a resin tooth bonding agent. It outlines the device's indications for use, its technical characteristics, and a comparison to predicate and reference devices. The core of the submission relies on bench testing to demonstrate substantial equivalence, rather than extensive clinical or human-in-the-loop studies commonly seen with AI/software as a medical device (SaMD).

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text, while noting the limitations in addressing all aspects of your request (particularly those related to AI/SaMD studies):

Acceptance Criteria and Reported Device Performance

Table 1: Acceptance Criteria and Novidia™ Universal Bond Performance

Test	Acceptance Criteria	Novidia™ Universal Bond Performance
Polymerization Conversion Degree	$\ge 70%$	Passed
Viscosity	$550 \pm 450 \text{ cP}$	Passed
Shear Bond Strength (Zirconia)	$\ge 10 \text{ MPa}$	Passed
Shear Bond Strength (Glass Ceramics)	(Implicitly $\ge 10 \text{ MPa}$ based on the Zirconia criterion being the general requirement for most materials)	Passed
Shear Bond Strength (Enamel)	(Implicitly $\ge 10 \text{ MPa}$ based on the Zirconia criterion being the general requirement for most materials)	Passed
Shear Bond Strength (Dentin)	(Implicitly $\ge 10 \text{ MPa}$ based on the Zirconia criterion being the general requirement for most materials)	Passed
Shear Bond Strength (Titanium)	(Implicitly $\ge 10 \text{ MPa}$ based on the Zirconia criterion being the general requirement for most materials)	Passed
Shear Bond Strength (Composite)	(Implicitly $\ge 10 \text{ MPa}$ based on the Zirconia criterion being the general requirement for most materials)	Passed
Shear Bond Strength (Amalgam)	$\ge 7 \text{ MPa}$	Passed
Micro Leakage	Penetration levels: 0 (no penetration) to 1 (only shallow enamel surface penetration).	Passed
Antibacterial Activity	Reduction of the viable bacteria	Passed

Note: The acceptance criteria for Shear Bond Strength for Glass Ceramics, Enamel, Dentin, Titanium, and Composite are not explicitly stated, but are implied to be $\ge 10 \text{ MPa}$ given the general structure of the table and the explicit criterion for Zirconia.

Study Details

The provided document describes a bench testing study to demonstrate substantial equivalence, rather than a clinical trial or AI model validation study.

1. Sample Size and Data Provenance for Test Set:

   • The document does not specify the exact sample sizes used for each bench test (e.g., number of samples for polymerization conversion, viscosity, or shear bond strength). It only states that "Non-clinical and biological testing was completed."
   • The data provenance is not explicitly mentioned in terms of country of origin or whether it was retrospective/prospective. As these are physical/chemical tests, data provenance in the context of geographical clinical data or time-based data collection methods (retrospective/prospective) is typically not applicable.

2. Number of Experts and Qualifications for Ground Truth:

   • This is not applicable to this type of study. The ground truth for the performance of a dental bonding agent, in this context, is established through standardized laboratory procedures and measurements (e.g., ISO standards for bond strength, chemical analysis for polymerization conversion). Expert consensus, common in diagnostic AI, is not relevant here.

3. Adjudication Method for Test Set:

   • Not applicable. Bench tests are objective measurements, not subjective evaluations requiring adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. The Novidia™ Universal Bond is a physical dental material, not an AI/SaMD.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop):

   • Not applicable in the AI/SaMD sense. The "performance" demonstrated is the physical and chemical properties of the material itself (e.g., bond strength, antibacterial activity) as measured in a lab, which is inherently "standalone" from a human interpretative loop.

6. Type of Ground Truth Used:

   • The ground truth was established through objective laboratory measurements based on established scientific principles and potentially ISO standards for material testing (e.g., ISO 10993 for biocompatibility, ISO 7405 for dental materials). It's not expert consensus, pathology, or outcomes data as would be the case for a diagnostic AI.

7. Sample Size for Training Set:

   • There is no mention of a training set because this is not an AI/machine learning device. The "training" for such a device would be the R&D and formulation process to develop the chemical composition and manufacturing procedures that yield the desired performance characteristics.

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

   • As there is no "training set" in the AI sense, this question is not applicable. The development of the ground truth (i.e., the target performance characteristics) for the material would be based on dental material science, clinical needs, and performance of existing predicate devices.

In summary, the provided document details the regulatory pathway for a dental material (Novidia™ Universal Bond) based on substantial equivalence demonstrated through rigorous non-clinical, bench testing, and biocompatibility assessments, adhering to established industry standards for dental materials. It largely differs from the typical safety and effectiveness studies required for AI/Software as a Medical Device (SaMD) which often involve clinical data, human reader performance studies, and complex expert ground truth establishment.

Regulation Number and Section

§ 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.