(78 days)
UltraTemp REZ II is indicated for temporization of provisional prosthesis or restorative provisional crowns, bridges, inlays, and on lays).
UltraTemp™ REZ II temporary resin cement is a low viscosity, temporary luting/filling material featuring a hydrophilic resin-based formula which is recommended for the retention of provisional restorations of provisional prosthesis. UltraTemp REZ II temporary resin cement may also be used for temporary restorative procedures (i.e. provisional crowns, bridges, inlays, and on lays). It is available in Fast Set (1 to 2 minutes) and Regular Set (2 to 3 minutes).
The provided text is a 510(k) Premarket Notification for a dental cement named UltraTemp Rez II. It describes the device, its intended use, and compares it to a predicate device (UltraTemp REZ). The document focuses on demonstrating substantial equivalence based on technological characteristics, rather than presenting a study of a device, especially not a device using AI, that would typically involve acceptance criteria related to classification performance metrics (like sensitivity, specificity, accuracy, etc.), expert adjudication, or MRMC studies.
Therefore, many of the requested items in your prompt are not applicable to the content of this document. This document is a regulatory submission for a dental material, not an AI/software device requiring performance validation in the way your prompt describes.
However, I can extract the information that is present and explain why other information is absent given the nature of the document.
Information Applicable to This Document:
- A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the context of classification task performance (e.g., sensitivity, specificity thresholds). Instead, it presents a comparison table (Table 5-1) showing various characteristics of the proposed device (UltraTemp REZ II) against its predicate device (UltraTemp REZ). The "reported device performance" are the physical properties and analytical tests conducted to demonstrate equivalence.
| Descriptive Information/Characteristic | Predicate: UltraTemp Firm, Fast and Regular Set (K080768) | Device: UltraTemp REZ II (K211237) | Identified Characteristic Differences and Rationale for Differences |
|---|---|---|---|
| Intended Use | For temporary application of provisional crowns, bridges, inlays, and on lays. | For temporization of provisional prosthesis or restorative procedures (i.e. provisional crowns, bridges, inlays, and on lays) | No identified differences |
| Intended User | Licensed Dentist or Dental Professional | Licensed Dentist or Dental Professional | Same intended user. No identified differences. |
| Characteristics | Low viscosity, non-eugenol, resin based temporary luting and filling material | Low viscosity, resin based temporary luting and filling material | The UTR and UTRII products vary in product formulas, see below for further discussions |
| Types of Materials | Polycarboxylate | Polycarboxylate | N/A |
| Formulation | Zinc Oxide Cement | Zinc Oxide Cement | N/A |
| Delivery System or Deployment Methods | Product is packaged in a dual-barrel syringe (catalyst and base) for use. When use is required, a mixing tip is attached to the dual barrel syringe, the product is then mixed within the syringe tip as it is expressed from the syringe into the treatment site. The product is workable for 2-3 minutes or 1-2 for the Regular Set configuration and Fast Set configuration respectively prior to the product becoming fully set | Same as predicate | N/A |
| Principles of Operation and Critical Performance Requirements | COA Release Testing: Appearance, Setting Time, Two-Spense Syringe Delivery Test | Same as predicate | N/A |
| Physical Properties (These are the "performance" relevant to this device) | Ultratemp Rez Regular Set and Fast Set Stability (internal Procedure): Accelerated in-house study performed on UltraTemp Firm Regular and Firm Fast set. 18 months shelf life at refrigerated temperatures Tensile Strength (Crown pulls)(internal Procedure): Analysis performed on UltraTemp REZ regular and UltraTemp REZ fast set. Results recorded. Regular Set: 9.73 ± 2.44 (Lbs). Fast Set: 11.32 ± 6.09 (Lbs) Compressive Strength and Modulus(internal Procedure): Analysis performed on UltraTemp REZ regular and UltraTemp REZ fast set. Results recorded. Regular Set: 29.25 ± 3.21 (MPa) Fast Set: 14.62 ± 1. 79 (MPa) Work and cure Time Test (internal Procedure): Analysis performed on UltraTemp REZ regular and UltraTemp REZ fast set. Results recorded. Regular Set: 45 seconds - 4 minutes to pass TST131 Fast Set: 30 seconds - 2 minutes to pass TST131 | Ultratemp Rez II Regular Set and Fast Set Stability: 12 to 18 months Shelf life, 2°C - 8°C Compression Strength (SOP_TST_0413.03): = 5 MPa Micro Leakage (test method as written in PRO_RD_00076.14): Minimal to no microleakage when compared to control Radio-Opacity (ISO4049:2019 Section 7.14): Radio-opacity >= 1mm Al Film Thickness (ISO 3107:2011 section 7.4): = 1.5 min and not >= 10 min. Additionally 45 seconds - 4 minutes as tested in TST131. Fast Set: 30 seconds - 2 minutes as tested in TST131 Water Removal (test method as written in PRO_TST_0413.03): Uncured chemical will easily come off glass slide after 10 seconds air/water spray Ultratemp Rez II Fast Set Only Acid-soluble arsenic mass fraction 2mg/kg maximum | N/A |
| Patient Population | Individuals of all ages and gender and shall be assessed by the administering dental professional. | Age: All ages; to be assessed by administering dental professional. Weight, gender, health and physical condition: All Conditions; to be assessed by administering dental professional. Part of the body interacted with: Applied to the prepared surfaces of enamel or dentin | N/A |
| Biocompatibility and Safety | Tested per ISO-10993-1 and ISO-7405 Cytotoxicity, Sensitization, irritation, and Genotoxicity testing passed. Literature and testing to demonstrate product is safe when used as directed Also, Considering the intended clinical applications and the results of the studies outlined in the biocompatibility summary found in section 8.1 of TF-00251, the evidence for the biological safety of UltraTemp REZ, regular and fast set, is adequate and there do not appear to be any significant toxicological risks associated with this product when used according to the manufacturer's instructions. Because UltraTemp REZ, regular and fast set is for professional use only, it is our belief that the available evidence for the biocompatibility of this product is adequate and no further studies are indicated. | Biological risks associated to patient safety for the UTRII product have been identified, assessed, and controlled/mitigated through the appropriate documentation. Chemical characterization, biocompatibility testing, and a health-based risk assessment was completed following ISO 10993-1 and subsequent standards. After review of the pertinent, objective evidence available, Ultradent Products, Inc. concludes that the biological and toxicological risks associated with the UTRII product are low and acceptable. | N/A |
Information Not Applicable or Not Provided in This Document:
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This document does not describe a clinical "test set" in the context of an AI/algorithm evaluation. The "studies" mentioned are laboratory tests of physical and chemical properties of the dental cement. Specific sample sizes for each physical/chemical test are not provided, nor is the data provenance in terms of country or retrospective/prospective nature, as these are typically conducted in a laboratory setting for material characterization.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of this material, relates to the measured physical and chemical properties, not a diagnostic classification established by experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there's no diagnostic test set requiring human adjudication.
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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 dental cement, not an AI-powered diagnostic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental cement, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device would be defined by the established physical and chemical standards for dental cements (e.g., ISO standards for film thickness, radio-opacity, mechanical strength). The document refers to internal procedures and ISO standards for these measurements.
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The sample size for the training set: Not applicable. This is a material, not a learning algorithm.
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How the ground truth for the training set was established: Not applicable.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.