UltraTemp Rez II

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 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). {4}------------------------------------------------ #### 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: {5}------------------------------------------------ #### Table 5-1: UltraTemp REZ II substantial equivalence comparison | Descriptive<br>Information/<br>Characteristic | Predicate: UltraTemp Firm, Fast<br>and Regular Set (K080768) | Device: UltraTemp REZ II<br>(K211237) | Identified Characteristic<br>Differences and Rationale for<br>Differences | |------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------| | Intended Use | For temporary application of<br>provisional crowns, bridges, inlays,<br>and on lays. | For temporization of provisional<br>prosthesis or restorative procedures<br>(i.e. provisional crowns, bridges, inlays,<br>and on lays) | No identified differences | | Intended User | Licensed Dentist or Dental<br>Professional | Licensed Dentist or Dental Professional | Same intended user. No identified<br>differences. | | Characteristics | Low viscosity, non-eugenol, resin<br>based temporary luting and filling<br>material | Low viscosity, resin based temporary<br>luting and filling material | The UTR and UTRII products vary<br>in product formulas, see below for<br>further discussions | | Types of Materials | Polycarboxylate | Polycarboxylate | N/A | | Formulation | Zinc Oxide Cement | Zinc Oxide Cement | N/A | | Delivery System or<br>Deployment Methods | Product is packaged in a dual-barrel<br>syringe (catalyst and base) for use.<br>When use is required, a mixing tip<br>is attached to the dual barrel<br>syringe, the product is then mixed<br>within the syringe tip as it is<br>expressed from the syringe into the<br>treatment site. The product is<br>workable for 2-3 minutes or 1-2 for<br>the Regular Set configuration and<br>Fast Set configuration respectively<br>prior to the product becoming fully<br>set | Same as predicate | N/A | | Principles of Operation<br>and Critical<br>Performance<br>Requirements | COA Release Testing:<br>Appearance, Setting Time, Two-<br>Spense Syringe Delivery Test | Same as predicate | N/A | | Physical Properties | Ultratemp Rez Regular Set and<br>Fast Set<br><br>Stability (internal Procedure):<br>Accelerated in-house study<br>performed on UltraTemp Firm<br>Regular and Firm Fast set. 18<br>months shelf life at refrigerated<br>temperatures | Ultratemp Rez II Regular Set and Fast<br>Set<br><br>Stability: 12 to 18 months Shelf life, 2°C<br>- 8°C<br><br>Compression Strength<br>(SOP_TST_0413.03): $ \le $ 35 MPa and $ \ge $ 5 MPa | N/A | {6}------------------------------------------------ # Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912 {7}------------------------------------------------ | Tensile Strength (Crown pulls)<br>(internal Procedure): Analysis<br>performed on UltraTemp REZ<br>regular and UltraTemp REZ fast set.<br>Results recorded. <b>Regular Set:</b> 9.73<br>$\pm$ 2.44 (Lbs). <b>Fast Set:</b> 11.32 $\pm$ 6.09<br>(Lbs} | Micro Leakage (test method as written<br>in PRO_RD_00076.14): Minimal to no<br>microleakage when compared to<br>control | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Compressive Strength and<br>Modulus(internal Procedure):<br>Analysis performed on UltraTemp<br>REZ regular and UltraTemp REZ fast<br>set. Results recorded. <b>Regular<br/>Set:</b> 29.25 $\pm$ 3.21 (MPa) <b>Fast Set:</b><br>14.62 $\pm$ 1. 79 (MPa) | Radio-Opacity (ISO4049:2019 Section<br>7.14): Radio-opacity $\geq$ 1mm Al | | Work and cure Time Test (internal<br>Procedure): Analysis performed on<br>UltraTemp REZ regular and<br>UltraTemp REZ fast set. Results<br>recorded. <b>Regular Set:</b> 45<br>seconds - 4 minutes to pass TST131<br><b>Fast Set:</b> 30 seconds - 2 minutes to<br>pass TST131 | Film Thickness (ISO 3107:2011 section<br>7.4): $\leq$ 25 $\mu$ m | | | UV Fluorescence (test method as<br>written in PRO_RD_00071): Sample<br>will fluoresce under UV light | | | Shear Bond Strength<br>(SOP_TST_0170.16): Control average –<br>sample average < 15 MPa | | | Working/Setting Time<br>(SOP_TST_0131.18): <b>Regular Set:</b><br>Setting time $\geq$ 1.5 min and not $\geq$ 10<br>min. Additionally 45 seconds - 4<br>minutes as tested in TST131. <b>Fast Set:</b><br>30 seconds - 2 minutes as tested in<br>TST131 | | | Water Removal (test method as<br>written in PRO_TST_0413.03): Uncured<br>chemical will easily come off glass slide<br>after 10 seconds air/water spray | {8}------------------------------------------------ | | | Ultratemp Rez II Fast Set Only | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----| | | | Acid-soluble arsenic mass fraction<br>2mg/kg maximum | | | Patient Population | Individuals of all ages and gender<br>and shall be assessed by the<br>administering dental professional. | Age:<br>All ages; to be assessed by<br>administering dental professional.<br>Weight, gender, health and physical<br>condition:<br>All Conditions; to be assessed by<br>administering dental professional.<br>Part of the body interacted with:<br>Applied to the prepared surfaces of<br>enamel or dentin | N/A | | Biocompatibility and<br>Safety | Tested per ISO-10993-1 and ISO-<br>7405<br>Cytotoxicity, Sensitization,<br>irritation, and Genotoxicity testing<br>passed. Literature and testing to<br>demonstrate<br>product is safe when used as<br>directed<br>Also, Considering the intended<br>clinical applications and the results<br>of the studies outlined in the<br>biocompatibility summary found in<br>section 8.1 of TF-00251, the | Biological risks associated to patient<br>safety for the UTRII product have been<br>identified, assessed, and<br>controlled/mitigated through the<br>appropriate documentation. Chemical<br>characterization, biocompatibility<br>testing, and a health-based risk<br>assessment was completed following<br>ISO 10993-1 and subsequent standards.<br>After review of the pertinent, objective<br>evidence available, Ultradent Products,<br>Inc. concludes that the biological and<br>toxicological risks associated with the<br>UTRII product are low and acceptable. | N/A | | evidence for the biological safety of<br>UltraTemp REZ, regular and fast<br>set, is adequate and there do not<br>appear to be any significant<br>toxicological risks associated with<br>this product when used according<br>to the manufacturer's instructions.<br>Because UltraTemp REZ, regular<br>and fast set is for professional use<br>only, it is our belief that the<br>available evidence for the<br>biocompatibility of this product is<br>adequate and no further studies<br>are indicated . | It can therefore be stated that the<br>UltraTemp REZ II product has been<br>evaluated for biological risks and the<br>UltraTemp REZ II product has been<br>determined to be biologically safe for<br>its intended uses. | | | {9}------------------------------------------------ {10}------------------------------------------------ ### 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.