(153 days)
The TOKUYAMA UNIVERSAL BOND II is indicated for:
- Direct anterior and posterior restorations with light-curing, dual-curing, and self-curing composite materials
- Intraoral repair of composite restorations, porcelain fused to metal, metal, and all-ceramic restorations without an additional primer
- Cementation of indirect restorations and veneers when combined with light-cure, dual-cure, and self-curing resin cements
- Bonding of core build-ups made of core build-up materials
- Bonding of denture resin to metal base, clasp or attachment
- Repair of denture with metal base, clasp or attachment
- Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns
The TOKUYAMA UNIVERSAL BOND II device is a two-component self-cured dental adhesive system for both direct and indirect restorations that can be used with self-etch, selective-enamel-etch and total-etch techniques. As a universal adhesive, TOKUYAMA UNIVERSAL BOND II has been designed to be fully compatible with light-cured, self-cured and dual-cured composite materials.
TOKUYAMA UNIVERSAL BOND II contains phosphoric acid monomer, bisphenol A di(2-hydroxy propoxy) dimethacrylate (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), 2-Hydroxyethyl methacrylate (HEMA), MTU-6 (thiouracil monomer), silane coupling agent, peroxide, borate catalyst, acetone, ethanol and purified water.
Bond A and Bond B are packaged in separate plastic bottles. A group of polymerization agents is contained in the Bond A and Bond B to avoid reaction during storage, and the polymerization reaction begins upon mixing. When the mixture is applied thinly to adherends and concentrated by air-drying, a cured layer is formed by polymerization of methacrylic monomers. The cured layer functions as an adhesive layer for enhancing adhesiveness of polymerization resin to the adherends.
The device improves the bond strength of polymerizable resin material (adhesive resin cement, acrylic resin, and composite resin) to indirect restorative materials such as glass-ceramics (porcelain), oxide-ceramics (zirconia and alumina), metals (precious and non-precious), and resin materials including inorganic filler.
The TOKUYAMA UNIVERSAL BOND device does not come sterilized and is not intended to be sterilized prior to use.
The provided document describes the TOKUYAMA UNIVERSAL BOND II, a dental adhesive. The acceptance criteria and the study to prove the device meets these criteria are outlined through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (In-house specification derived from predicate device) | Reported Device Performance (TOKUYAMA UNIVERSAL BOND II) |
|---|---|
| Enamel: ≥ 12 MPa | Performance met or exceeded this value (implied by "Similar" in comparison table and "concluded that the TOKUYAMA UNIVERSAL BOND II device is substantially equivalent to the primary predicate device"). Specific values are not provided in the summary. |
| Dentin: ≥ 10 MPa | Performance met or exceeded this value (implied). Specific values are not provided in the summary. |
| Metal: ≥ 12 MPa | Performance met or exceeded this value (implied). Specific values are not provided in the summary. |
| Porcelain: ≥ 10 MPa | Performance met or exceeded this value (implied). Specific values are not provided in the summary. |
| Zirconia: ≥ 10 MPa | Performance met or exceeded this value (implied). Specific values are not provided in the summary. |
| Resin material including inorganic filler: ≥ 10 MPa | Performance met or exceeded this value (implied). Specific values are not provided in the summary. |
| Working time: Not cured after three minutes | Device was confirmed not cured after three minutes. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes (number of replicates or specimens) used for each tensile bond strength test. However, it indicates that testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015. This ISO standard typically specifies details on sample preparation and testing procedures.
The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Tokuyama Dental Corporation, located in Tokyo, Japan. The testing is non-clinical bench testing, so it is retrospective in the sense that it evaluates the manufactured device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This is a non-clinical bench testing study for a dental adhesive, not a study involving diagnostic interpretation or human expert judgment to establish ground truth for a test set. The ground truth for performance is objective physical measurements based on established ISO standards.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this is non-clinical bench testing with objective physical measurements. There is no subjective adjudication required.
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 non-clinical study for a dental adhesive, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a non-clinical study for a dental adhesive, not an algorithm. The device's performance is measured standalone from human intervention other than its application as per the instructions for use.
7. The Type of Ground Truth Used:
The ground truth used for performance evaluation is objective physical measurements of tensile bond strength and working time, compared against pre-defined in-house specifications (derived from the predicate device) and ISO standards. Biocompatibility was also assessed in accordance with ISO 10993-1:2009.
8. The Sample Size for the Training Set:
Not applicable. This device is a dental adhesive, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As this is not an AI/ML algorithm, there is no training set or associated ground truth establishment process.
§ 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.