J-Temp

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July 1, 2022 Ultradent Products, Inc. % Dave Yungvirt Most Responsible Person Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059 Re: K221909 Trade/Device Name: J-Temp Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: Class II Product Code: EBF Dated: June 27, 2022 Received: June 30, 2022 Dear Dave Yungvirt: 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. {1}------------------------------------------------ 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 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 (QS) 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K221909 Device Name J-Temp Indications for Use (Describe) ·Temporary restorations ·Splinting between implant copings for impressions to resist impression material distortion ·To provide structure for isolation clamping and to act as a barrier for endodontic irrigants · Bite ramps and temporary occlusal buildups during orthodontics Type of Use (Select one or both, as applicable) | <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |------------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # K221909 # 510(k) Summary This summary of the traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 J-Temp. ## l. Applicant's Name and Address Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 | Contact Person: | Mr. Matthew Buck | |-----------------|-----------------------------------| | Title: | Regulatory Affairs Specialist III | | Telephone: | 801-553-4339 | | Cell Phone: | 801-201-2371 | | Fax: | 801-553-4609 | Date Summary Prepared: 20 May 2022 #### II. Name of the Device | Device: | Material, Tooth Shade, Resin | |------------------------------|------------------------------| | Trade/Device Name: | J-Temp | | Common Name: | Material, Tooth Shade, Resin | | Review Panel: | Dental | | Regulation Number: | 21 CFR 872.3690 | | Device Class: | Class II | | Classification Product Code: | EBF | #### III. Device Description J-Temp temporary resin is a flowable resin material designed to be durable enough to stay in place after being applied. It is delivered via syringe and light cured. #### IV. Statement of Intended Use J-Temp is indicated for - Temporary restorations ● - . Splinting between implant copings for impressions to resist impression material distortion. {4}------------------------------------------------ - . To provide structure for isolation clamping and to act as a barrier for endodontic irrigants - . Bite ramps and temporary occlusal buildups during orthodontics ### V. Predicate Device J-Temp identified primary predicate: Clip Flow by Voco (K153493) ## VII. Comparison of Technological Characteristics #### Predicate technological comparison: The technology, delivery, and intended use of J-Temp 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: Clip Flow<br>(K153493) | Device: J-Temp | Reference: Venus Flow<br>(K033665) | Reference: TKO<br>Composite Bite<br>Turbo Gel<br>(K210349) | Identified Characteristic<br>Differences and Rationale for<br>Differences | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | EBF | EBF | EBF | EBF | Same | | Intended Use | [A] Temporary inlay<br>and onlay treatments<br>of the cavity<br>[B] Sealing of openings<br>for implant screws<br>[C] Relining material<br>for temporary crowns<br>and bridges<br>[D] Block-out material<br>for retentive areas in<br>the dental arch, e.g.<br>before taking<br>impressions<br>[E] Covering of the<br>gingival margin<br>[F] Fixing of resin<br>matrix during filling<br>placement<br>[G] Temporary filling<br>of cavities | •Temporary<br>restorations<br>•Splinting between<br>implant copings for<br>impressions to resist<br>impression material<br>distortion<br>•To provide structure<br>for isolation clamping<br>and to act as a barrier<br>for endodontic<br>irrigants<br>•Bite ramps and<br>temporary occlusal<br>buildups during<br>orthodontics | Venus flow is a flowable,<br>light curing, radiopaque<br>hyrbrid composite used for<br>adhesive, tooth-colored<br>anterior and posterior<br>restorations. Due to its low<br>viscosity Venus Flow<br>provides excellent coverage<br>tooth structure.<br><br>Applicable applications<br>includes:<br>Baseliner in Class I & II<br>cavities; Fissure sealing;<br>Enlarged fissure sealing;<br>Class V fillings; Minimally<br>invasive Class I and II fillings<br>in areas not subjected to<br>masticatory forces;<br>Minimally invasive Class III<br>fillings; Smaller contour and<br>shade adjustment on the<br>enamel and dentine; Small<br>surface repairs to direct and<br>indirect restorative in | TKO is a pink,<br>flowable light<br>cure composite<br>gel for the<br>creation of<br>occlusal buildups<br>(bite turbos) and<br>as a retainer<br>repair<br>composite. | Both Clip Flow and J-Temp have the<br>same intended use with minor<br>differences in their Indications for<br>use. Clip Flow is indicated for<br>temporary inlay and onlay<br>treatments of the cavity, temporary<br>filling of cavities. J-Temp is<br>indicated for temporary<br>restorations. J-Temp is indicated for<br>providing structure for isolation<br>clamping acting as a barrier for<br>endodontic irrigants, because when<br>cured it is harder than Clip Flow it<br>can be used in this specific<br>procedure as part of a temporary<br>filling. Because J-Temp is harder<br>when cured it can be indicated for<br>splinting between implant copings<br>for impressions to resist impression<br>material distortion, like the<br>reference device Venus Flow which<br>has an indication to splint teeth. J-<br>Temp can also be indicated for Bite<br>ramps and temporary occlusal<br>buildups during orthodontics like | | | | | combination with a suitable<br>bonding agent; <b>Splinting<br/>teeth</b> ; Cavity lining;<br>Bracket retention; Sealing<br>endodontically treated<br>teeth; Luting porcelain or<br>composite veneers; Filling<br>in voids in temporary crown<br>and bridges materials | | the reference device TKO<br>Composite Bite Turbo Gel. | | Intended User | Licensed Dentist or<br>Dental Professional | Licensed Dentist or<br>Dental Professional | Licensed Dentist or Dental<br>Professional | Dental<br>Professional | Same intended user. No identified<br>differences. | | Characteristics | • Flowable, light-<br>cured temporary<br>restorative<br>material.<br>• Elastic consistency<br>and removable with<br>probe. | • Flowable, light-<br>cured temporary<br>restorative<br>material.<br>• Cured resin<br>removable with<br>dental bur. | • Flowable, light-cured<br>restorative material. | • Flowable,<br>light-cured<br>composite Gel | Clip Flow and J-Temp are flowable<br>light-cured temporary restorative<br>materials. They are both intended<br>to be easily removed as temporary<br>materials unlike the reference<br>devices. | | Composition | • Methacrylates<br>• Light cure initiators<br>BHT | • Methacrylates<br>• Light cure initiators<br>• Glass ionomer fillers<br>Pigments | • Methacrylates<br>• Light cure initiators<br>• Barium Aluminum Boro<br>Fluor Silicate fillers<br>• Pigments<br>• BHT | • Methacrylates<br>• Light cure<br>initiators<br>Pigments | Clip Flow and TKO Composite Bite<br>Turbo Gel don't have fillers.<br><br>Rationale for differences: J-Temp<br>and Venus Flow have indications for<br>use that require a harder material.<br>J-Temp doesn't need BHT which is<br>free radical inhibitor. | | Delivery System<br>or Deployment<br>Methods | Product is provided in<br>a 1.8g syringe with<br>disposable delivery<br>tips | Product is provided in<br>a 1.2mL syringe with<br>disposable delivery<br>tips | Product is provided in a<br>1.8g syringe | Product is<br>provided in a<br>precision 3.5 gm<br>LuerLoc syringe<br>with tips | Clip Flow and the J-Temp are<br>provided in similar delivery syringes<br>along with the reference devices. | | Physical<br>Properties | Flowable Used with tips. Light cured ≤ 5 % shrinkage ≥ 10 HK Hardness ≥ 1 mm depth of cure | Flowable Used with tips. Light cured ≤ 5 % shrinkage ≥ 10 HK Hardness ≥ 1 mm depth of cure Light sensitivity greater than 60 seconds ≥ 2 MPa Flexural Strength ≥ 180 MPa Compressive Strength Remove with bur Radio-opaque | Flowable Used with tips. Light cured ≥ 1 mm depth of cure Light sensitivity greater than 60 seconds ≥ 2 MPa Flexural Strength ≥ 180 MPa Compressive Strength Remove with bur Radio-opaque | Flowable Used with tips. Light cured. ≥ 10 HK Hardness ≥ 1 mm depth of cure Light sensitivity greater than 60 seconds ≥ 2 MPa Flexural Strength ≥ 180 MPa Compressive Strength Remove with bur | J-Temp is harder when cured than<br>Clip Flow. J-Temp has a hardness<br>value comparable to TKO<br>Composite Bite Turbo Gel. J-Temp's<br>flexural strength is less than Venus<br>Flow and to TKO Composite Bite<br>Turbo Gel. J-Temp is radio-opaque,<br>and Clip Flow is not radio-opaque. | | Patient<br>Population | is suitable for use in all<br>patients without any<br>age or gender<br>restrictions | Individuals of all ages<br>and gender and shall<br>be assessed by the<br>administering dental<br>professional. | The dental material is<br>suitable for patients<br>requiring dental treatment<br>for the indications | Individuals<br>receiving<br>orthodontic<br>treatment. | N/A | | | | | with consideration of the<br>contraindications. | | | | Biocompatibility<br>and Safety | Biocompatible | Tested per ISO 7405,<br>ISO 10993-1<br>•Physical/Chemical<br>Information<br>•Systemic Toxicity<br>•Genotoxicity<br>•Cytotoxicity<br>•Sensitization<br>•Irritation<br>•Implantation Effects | Biocompatible | ISO 10993-5<br>ISO 7405:2018 | The Clip Flow and J-Temp are<br>shown to be biocompatible as well<br>as the reference devices. | | | | | | | | {6}------------------------------------------------ {7}------------------------------------------------ #### Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912 {8}------------------------------------------------ ### Ultradent Products, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095 Est. Reg. No. 1718912 {9}------------------------------------------------ ### VII Conclusion: As outlined in the comparison table above, J-Temp 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, J-Temp does not introduce any new safety or efficacy issues, questions or concerns per Biocompatibility and Safety testing that has been completed. The subject device also successfully passed all verification and validation testing. In summary it can be stated that the development of the subject J-Temp product is based on a well-established technology in the form of the predicate Clip Flow product. Based on these comparisons to the predicate device, we believe that J-Temp is substantially equivalent to the predicate device and do not raise new concerns of safety or efficacy.