UltraCal XS

{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. October 13, 2021 Ultradent Products, Inc. Adam Black Regulatory Affairs Manager 505 West Ultradent Drive (10200 South) South Jordan, Utah 84095 Re: K211905 Trade/Device Name: UltraCal XS Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF, EJK Dated: July 15, 2021 Received: July 16, 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) K211905 Device Name UltraCal XS Indications for Use (Describe) UltraCal XS calcium hydroxide paste is indicated to be used for: · temporary dressing for root canals - apexification and/or perforation - · vital pulpotomy - direct pulp capping - · indirect pulp capping - · root resorption - root canal filling for primary teeth 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-K211905 This summary of the traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 for UltraCal XS. ## 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: 22 September 2021 ## II. Name of the Device | Device: | Resin, Root Canal Filling | |------------------------------|---------------------------| | Trade/Device Name: | UltraCal XS | | Common Name: | Root Canal Filling Resin | | Review Panel: | Dental | | Regulation Number: | 21 CFR 872.3820 | | Device Class: | Class II | | Classification Product Code: | KIF | | Subsequent Product Code: | EJK | ## III. Device Description UltraCal XS calcium hydroxide paste is an aqueous, 12.0 to 12.5 pH, radiopaque, premixed paste for direct application. # IV. Statement of Intended Use UltraCal XS calcium hydroxide paste is indicated to be used for: - . Temporary dressing for root canals - . Apexification and/or perforation {4}------------------------------------------------ - Vital Pulpotomy - Direct Pulp Capping - Indirect Pulp Capping - Root resorption - Root canal filling for primary teeth # V. Predicate Device UltraCal XS identified primary predicate: DiaPaste (K210333); secondary predicates: CleaniCal (K201799), TheraCal DC (K180344), Dia-Root Bio MTA (K200174). # VII. Comparison of Technological Characteristics ## Predicate technological comparison: The technology, delivery, and intended use of UltraCal XS are substantially equivalent to the identified predicate as outlined in Table 5-1: {5}------------------------------------------------ # Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912 #### Table 5-1: UltraCal XS substantial equivalence comparison | Descriptive<br>Information/<br>characteristic | Primary Predicate:<br>DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:<br>CleaniCal (K201799) | Secondary Predicate:<br>TheraCal DC (K180344) | Secondary Predicate:<br>Dia-Root Bio MTA<br>(K200174) | Differences | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | KIF | KIF, EJK | EJK, KIF | EJK | KIF | Similar | | Intended Use | Aqueous ointment<br>material that<br>temporarily fills the<br>root canal for the<br>following indications:<br>-Apexification<br>-Temporary root filling<br>-Root canal filling for<br>primary teeth<br>-Vital pulpotomy<br>-Temporary pulp<br>capping | UltraCal XS calcium<br>hydroxide paste is<br>indicated to be used<br>for:<br>•Temporary dressing<br>for root canals<br>•Apexification and/or<br>perforation<br>•Vital Pulpotomy<br>•Direct Pulp Capping<br>•Indirect Pulp Capping<br>•Root resorption<br>•Root canal filling for<br>primary teeth | CleaniCal is a Calcium<br>Hydroxide paste that<br>has a creamy<br>consistency and is<br>suitable for several<br>indications including.<br>-Temporary<br>disinfectant dressings<br>in the obturation of<br>root canals<br>-Indirect pulp capping<br>or management of<br>deep caries lesions; or<br>-Direct pulp capping | 1. Pulpotomy<br>2. Temporary Filling<br>Material<br>3. Repair of Root<br>Perforations<br>4. Repair of Furcation<br>Perforations<br>5. Repair of Perforating<br>Internal and External<br>Resorptions<br>6. Root-End Filling in<br>Endodontic Surgery<br>7. Pulp Exposures (Direct<br>Pulp Capping)<br>8. Protective Liner<br>(Indirect Pulp Capping)<br>and Base for Use Under<br>a Variety of Substrates | DIA-ROOT BIO MTA is<br>used for pulp capping<br>(direct pulp capping or<br>partial pulpotomy) and<br>repair of root perforation.<br>Other indications for use<br>include: repair of root<br>resorption, root end<br>filling, apexification and<br>pulpotomy. | Similar<br>The Indications for Use<br>of the subject device is<br>within that of the<br>predicate and<br>reference device(s). | | Intended User | Licensed Dentist or<br>Dental Professional | Licensed Dentist or<br>Dental Professional | Dental Professional | Dental Professional | Dental Professional | Identical | | Characteristics | Calcium hydroxide<br>paste with barium<br>sulfate, used as a | Aqueous 12.0 to 12.5<br>pH calcium hydroxide,<br>radiopaque, premixed | Pre-filled syringe with<br>calcium hydroxide<br>paste with a pH of 12.3. | TheraCal DC is a<br>biocompatible, basic,<br>dual-cured, resin- | | Similar<br>The subject device as<br>well as the predicate | | Descriptive<br>Information/<br>characteristic | Primary Predicate:<br>DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:<br>CleaniCal (K201799) | Secondary Predicate:<br>TheraCal DC (K180344) | Secondary Predicate:<br>Dia-Root Bio MTA<br>(K200174) | Differences | | | temporary root canal<br>filling material. | paste for direct<br>application. | | modified calcium silicate<br>provided in a pre-filled<br>syringe | | and reference device(s)<br>are both calcium<br>hydroxide paste with<br>relatively high pH. | | Composition | -Calcium Hydroxide<br>-Titanium Dioxide<br>-Zinc Oxide<br>-Barium Sulfate<br>-Water<br>-Polyether Polyol<br>-Polysorbate<br>(Tween80) | -Calcium hydroxide<br>-Water<br>-Barium Sulfate<br>-Propylene Glycol<br>-Hydroxypropyl<br>Methylcellulose | -Calcium hydroxide<br>-Zirconium dioxide<br>- Excipients (nMethyl-2-<br>pyrrolidone,<br>Hypromellose) | -Calcium hydroxide<br>-Portland Cement<br>-All other components<br>are proprietary | -Calcium silicate<br>-Zirconium dioxide<br>-Citric Acid<br>-Silanamine, 1,1,1-<br>trimethyl-N-<br>(trimethylsilyl-,hydrolysis<br>products with silica<br>-Hydroxypropyl<br>methylcellulose | Similar<br>The primary ingredient<br>is equivalent in the<br>predicate and subject<br>device, calcium<br>hydroxide. Barium<br>sulfate is included in<br>both as a radio-<br>opacifier. Differences in<br>the ingredients<br>included varying<br>chemicals used as<br>thickeners,<br>humectants,<br>emulsifiers, etc.<br>Dia-Root Bio MTA does<br>not include calcium<br>hydroxide as a<br>component, however<br>the hydration reaction<br>during setting occurs<br>between tricalcium | | Descriptive<br>Information/<br>characteristic | Primary Predicate:<br>DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:<br>CleaniCal (K201799) | Secondary Predicate:<br>TheraCal DC (K180344) | Secondary Predicate:<br>Dia-Root Bio MTA<br>(K200174) | Differences | | | | | | | | silicate $(3CaO·SiO2)$ and<br>dicalcium silicate<br>$(2CaO·SiO2)$ to form a<br>calcium hydroxide and<br>calcium silicate hydrate<br>gel, producing an<br>alkaline pH. | | Delivery System<br>or Deployment<br>Methods | Product is provided in<br>a 2g syringe with<br>disposable delivery<br>tips | Product is provided in<br>a 1.2mL syringe with<br>disposable delivery<br>tips | Pre-loaded syringe | Pre-loaded syringe | Powder within a cap &<br>body to be mixed with<br>distilled water on a<br>mixing pad and applied<br>intraorally with a spatula | Similar<br>Both the subject device<br>and the predicate and<br>reference devices are<br>provided in a pre-filled<br>syringe with or without<br>delivery tips.<br>The difference with<br>Dia-Root Bio MTA<br>delivery is based on the<br>necessary reaction with<br>water to achieve<br>performance. | | Descriptive<br>Information/<br>characteristic | Primary Predicate:<br>DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:<br>CleaniCal (K201799) | Secondary Predicate:<br>TheraCal DC (K180344) | Secondary Predicate:<br>Dia-Root Bio MTA<br>(K200174) | Differences | | Physical<br>Properties | Confirmed to ISO 6876<br>-Flowability<br>-Film Thickness<br>-Radio-opacity | -Viscosity<br>-Water Removal<br>-Radio-Opacity | Confirmed to ISO 6876<br>-Packaging<br>-Extraneous matter<br>-Flowability<br>-Radio-opacity | Confirmed to ISO 6876<br>-Radiopaque<br>-Calcium releasing<br>-Basic<br>-Water sorption<br>-Solubility | Confirmed to ISO 6876<br>-Setting time<br>-Solubility<br>-Radiopacity | Similar<br>ISO 6876 is applicable<br>for root canal sealing<br>material, as UltraCal XS<br>is not intended to seal<br>root canals and was<br>therefore deemed not<br>applicable. Similar<br>testing was performed<br>to evaluate the<br>characteristics of the<br>chemistry. | | Calcium<br>Hydroxide<br>Concentration | 22-26% | 35% | 30% | Not specified | Not specified - based on<br>ratio of distilled water<br>and calcium silicate used | Similar<br>Concentration range is<br>within ranges cleared<br>by FDA and does not<br>raise new questions<br>regarding safety and<br>efficacy. | | Patient<br>Population | Individuals of all ages<br>and gender and shall<br>be assessed by the<br>administering dental<br>professional. | Individuals of all ages<br>and gender and shall<br>be assessed by the<br>administering dental<br>professional. | Individuals of all ages<br>and gender and shall be<br>assessed by the<br>administering dental<br>professional. | Not specified | Not specified | Identical | | Descriptive<br>Information/<br>characteristic | Primary Predicate:<br>DiaPaste (K210333) | Device: UltraCal XS | Secondary Predicate:<br>CleaniCal (K201799) | Secondary Predicate:<br>TheraCal DC (K180344) | Secondary Predicate:<br>Dia-Root Bio MTA<br>(K200174) | Differences | | Biocompatibility<br>and Safety | ISO 10993 | ISO 7405:2018 | ISO 10993 | ISO 7405:2008<br>ISO 10993-1:2009 | ISO 7405:2018 | ISO 7405 was applied<br>as it is a recommended<br>biocompatibility<br>evaluation standard for<br>this product type. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ # VII Conclusion: The purpose of this submission was to address the change in indications for use of the previously submitted UltraCal XS (K970114). As outlined in the comparison table above, UltraCal XS 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. The subject device also successfully passed all verification and validation testing, including the biocompatibility assessment. In summary it can be stated that the development of the subject device, UltraCal XS, is based on a well-established technology in the form of the predicate device, DiaPaste (K210333) and is chemically equivalent to the previously submitted UltraCal XS (K970114). The decision to rely on DiaPaste (K210333) as the predicate rather than the previously submitted UltraCal XS (K970114) is due to the updated indications of the subject device. In order to establish substantial equivalence, DiaPaste (K210333) was selected as the best fit predicate based off of chemistry and cleared indications for use. Based on the completed testing and the comparisons to the predicate device, we believe that UltraCal XS is substantially equivalent to the predicate device and does not raise any different questions regarding safety and effectiveness.