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510(k) Data Aggregation
(367 days)
Ambar, Ambar APS, Ambar Universal APS
- 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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