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).

AI/ML Overview

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 $\pm$ 2.44 (Lbs). Fast Set: 11.32 $\pm$ 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 $\pm$ 3.21 (MPa) Fast Set: 14.62 $\pm$ 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): <= 35 MPa and >= 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): <= 25 µ m UV Fluorescence (test method as written in PRO_RD_00071): Sample will fluoresce under UV light Shear Bond Strength (SOP_TST_0170.16): Control average – sample average < 15 MPa Working/Setting Time (SOP_TST_0131.18): Regular Set: Setting time >= 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:

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.
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.
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.
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.
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.
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.
The sample size for the training set: Not applicable. This is a material, not a learning algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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July 13, 2021

Ultradent Products, Inc. Adam Black Regulatory Affairs Manager 505 W. Ultradent Drive (10200 South) South Jordan, Utah 84095

Re: K211237

Trade/Device Name: UltraTemp Rez II Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: May 13, 2021 Received: May 14, 2021

Dear Adam Black:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211237

Device Name UltraTemp Rez II

Indications for Use (Describe)
Indications for use:
UltraTemp BEZ II is indicated

UltraTemp REZ II is indicated for temporization of provisional prosthesis or restorative provisional crowns, bridges, inlays, and on lays).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary-K211237

This summary of the traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 UltraTemp REZ II.

l. Applicant's Name and Address

Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095

Contact Person:	Mr. Adam Black
Title:	Regulatory Affairs Manager
Telephone:	801-553-4425
Cell Phone:	435-459-9302
Fax:	801-553-4609

Date Summary Prepared: 08 July 2021

II. Name of the Device

Device:	Cement, Dental
Trade/Device Name:	UltraTemp REZ II
Common Name:	Cement, Dental
Review Panel:	Dental
Regulation Number:	21 CFR 872.3275
Device Class:	Class II
Classification Product Code:	EMA

III. Device Description

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IV. Statement of Intended Use

UltraTemp REZ II is indicated for temporization of provisional prosthesis or restorative procedures (i.e. provisional crowns, bridges, inlays, and on lays)

V. Predicate Device

UltraTemp REZ II identified primary predicate: UltraTemp REZ (UltraTemp Firm, Fast and Regular Set (K080768)

VII. Comparison of Technological Characteristics

Predicate technological comparison:

The technology, delivery, and intended use of UltraTemp REZ II are substantially equivalent to the identified predicate as outlined in Table 5-1:

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Table 5-1: UltraTemp REZ II substantial equivalence comparison

DescriptiveInformation/Characteristic	Predicate: UltraTemp Firm, Fastand Regular Set (K080768)	Device: UltraTemp REZ II(K211237)	Identified CharacteristicDifferences and Rationale forDifferences
Intended Use	For temporary application ofprovisional crowns, bridges, inlays,and on lays.	For temporization of provisionalprosthesis or restorative procedures(i.e. provisional crowns, bridges, inlays,and on lays)	No identified differences
Intended User	Licensed Dentist or DentalProfessional	Licensed Dentist or Dental Professional	Same intended user. No identifieddifferences.
Characteristics	Low viscosity, non-eugenol, resinbased temporary luting and fillingmaterial	Low viscosity, resin based temporaryluting and filling material	The UTR and UTRII products varyin product formulas, see below forfurther discussions
Types of Materials	Polycarboxylate	Polycarboxylate	N/A
Formulation	Zinc Oxide Cement	Zinc Oxide Cement	N/A
Delivery System orDeployment Methods	Product is packaged in a dual-barrelsyringe (catalyst and base) for use.When use is required, a mixing tipis attached to the dual barrelsyringe, the product is then mixedwithin the syringe tip as it isexpressed from the syringe into thetreatment site. The product isworkable for 2-3 minutes or 1-2 forthe Regular Set configuration andFast Set configuration respectivelyprior to the product becoming fullyset	Same as predicate	N/A
Principles of Operationand CriticalPerformanceRequirements	COA Release Testing:Appearance, Setting Time, Two-Spense Syringe Delivery Test	Same as predicate	N/A
Physical Properties	Ultratemp Rez Regular Set andFast SetStability (internal Procedure):Accelerated in-house studyperformed on UltraTemp FirmRegular and Firm Fast set. 18months shelf life at refrigeratedtemperatures	Ultratemp Rez II Regular Set and FastSetStability: 12 to 18 months Shelf life, 2°C- 8°CCompression Strength(SOP_TST_0413.03): $ \le $ 35 MPa and $ \ge $ 5 MPa	N/A

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Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912

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Tensile Strength (Crown pulls)(internal Procedure): Analysisperformed on UltraTemp REZregular and UltraTemp REZ fast set.Results recorded. Regular Set: 9.73$\pm$ 2.44 (Lbs). Fast Set: 11.32 $\pm$ 6.09(Lbs}	Micro Leakage (test method as writtenin PRO_RD_00076.14): Minimal to nomicroleakage when compared tocontrol
Compressive Strength andModulus(internal Procedure):Analysis performed on UltraTempREZ regular and UltraTemp REZ fastset. Results recorded. RegularSet: 29.25 $\pm$ 3.21 (MPa) Fast Set:14.62 $\pm$ 1. 79 (MPa)	Radio-Opacity (ISO4049:2019 Section7.14): Radio-opacity $\geq$ 1mm Al
Work and cure Time Test (internalProcedure): Analysis performed onUltraTemp REZ regular andUltraTemp REZ fast set. Resultsrecorded. Regular Set: 45seconds - 4 minutes to pass TST131Fast Set: 30 seconds - 2 minutes topass TST131	Film Thickness (ISO 3107:2011 section7.4): $\leq$ 25 $\mu$ m
	UV Fluorescence (test method aswritten in PRO_RD_00071): Samplewill fluoresce under UV light
	Shear Bond Strength(SOP_TST_0170.16): Control average –sample average < 15 MPa
	Working/Setting Time(SOP_TST_0131.18): Regular Set:Setting time $\geq$ 1.5 min and not $\geq$ 10min. Additionally 45 seconds - 4minutes as tested in TST131. Fast Set:30 seconds - 2 minutes as tested inTST131
	Water Removal (test method aswritten in PRO_TST_0413.03): Uncuredchemical will easily come off glass slideafter 10 seconds air/water spray

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		Ultratemp Rez II Fast Set Only
		Acid-soluble arsenic mass fraction2mg/kg maximum
Patient Population	Individuals of all ages and genderand shall be assessed by theadministering dental professional.	Age:All ages; to be assessed byadministering dental professional.Weight, gender, health and physicalcondition:All Conditions; to be assessed byadministering dental professional.Part of the body interacted with:Applied to the prepared surfaces ofenamel or dentin	N/A
Biocompatibility andSafety	Tested per ISO-10993-1 and ISO-7405Cytotoxicity, Sensitization,irritation, and Genotoxicity testingpassed. Literature and testing todemonstrateproduct is safe when used asdirectedAlso, Considering the intendedclinical applications and the resultsof the studies outlined in thebiocompatibility summary found insection 8.1 of TF-00251, the	Biological risks associated to patientsafety for the UTRII product have beenidentified, assessed, andcontrolled/mitigated through theappropriate documentation. Chemicalcharacterization, biocompatibilitytesting, and a health-based riskassessment was completed followingISO 10993-1 and subsequent standards.After review of the pertinent, objectiveevidence available, Ultradent Products,Inc. concludes that the biological andtoxicological risks associated with theUTRII product are low and acceptable.	N/A
evidence for the biological safety ofUltraTemp REZ, regular and fastset, is adequate and there do notappear to be any significanttoxicological risks associated withthis product when used accordingto the manufacturer's instructions.Because UltraTemp REZ, regularand fast set is for professional useonly, it is our belief that theavailable evidence for thebiocompatibility of this product isadequate and no further studiesare indicated .	It can therefore be stated that theUltraTemp REZ II product has beenevaluated for biological risks and theUltraTemp REZ II product has beendetermined to be biologically safe forits intended uses.

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VII Conclusion:

UltraTemp REZ II product was designed and developed to be the replacement product for UltraTemp REZ. As outlined in the comparison table above, UltraTemp REZ II is similar to the identified predicate device with respect to its intended Use, its Intended User, the Device Design, Types of Material used, Delivery System and or Deployment Method, Physical Properties and Patient Population. Also, UltraTemp REZ II does not introduce any new safety or efficacy issues, questions or concerns per Biocompatibility and Safety testing has been completed.

In summary it can be stated that the development of the subject UltraTemp REZ II product is based on a well-established technology in the form of the predicate UltraTemp REZ product. Based on these comparisons to the predicate device, we believe that UltraTemp REZ II is substantially equivalent to the predicate device and do not raise new concerns of safety or efficacy.

Regulation Number and Section

§ 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.