•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

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.

AI/ML Overview

This document does not contain information about acceptance criteria and study details for device performance. It is an FDA 510(k) premarket notification for a dental resin material named "J-Temp", primarily focusing on its substantial equivalence to a predicate device ("Clip Flow" by Voco).

While a table comparing technological characteristics is provided, it outlines similarities and differences between the new device and predicate devices in terms of intended use, composition, physical properties, etc. However, this table does not include:

Specific acceptance criteria (e.g., numerical thresholds for performance metrics).
Reported device performance against such criteria.
Details about a study designed to prove the device meets acceptance criteria, including sample sizes, ground truth establishment, expert involvement, or comparative effectiveness.

The document states that the device "successfully passed all verification and validation testing," but it does not provide any specifics about these tests, the acceptance criteria used, or the results obtained.

Therefore, I cannot provide the requested information from the given text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)

☑ 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}------------------------------------------------

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

DescriptiveInformation/characteristic	Predicate: Clip Flow(K153493)	Device: J-Temp	Reference: Venus Flow(K033665)	Reference: TKOComposite BiteTurbo Gel(K210349)	Identified CharacteristicDifferences and Rationale forDifferences
Product Code	EBF	EBF	EBF	EBF	Same
Intended Use	[A] Temporary inlayand onlay treatmentsof the cavity[B] Sealing of openingsfor implant screws[C] Relining materialfor temporary crownsand bridges[D] Block-out materialfor retentive areas inthe dental arch, e.g.before takingimpressions[E] Covering of thegingival margin[F] Fixing of resinmatrix during fillingplacement[G] Temporary fillingof cavities	•Temporaryrestorations•Splinting betweenimplant copings forimpressions to resistimpression materialdistortion•To provide structurefor isolation clampingand to act as a barrierfor endodonticirrigants•Bite ramps andtemporary occlusalbuildups duringorthodontics	Venus flow is a flowable,light curing, radiopaquehyrbrid composite used foradhesive, tooth-coloredanterior and posteriorrestorations. Due to its lowviscosity Venus Flowprovides excellent coveragetooth structure.Applicable applicationsincludes:Baseliner in Class I & IIcavities; Fissure sealing;Enlarged fissure sealing;Class V fillings; Minimallyinvasive Class I and II fillingsin areas not subjected tomasticatory forces;Minimally invasive Class IIIfillings; Smaller contour andshade adjustment on theenamel and dentine; Smallsurface repairs to direct andindirect restorative in	TKO is a pink,flowable lightcure compositegel for thecreation ofocclusal buildups(bite turbos) andas a retainerrepaircomposite.	Both Clip Flow and J-Temp have thesame intended use with minordifferences in their Indications foruse. Clip Flow is indicated fortemporary inlay and onlaytreatments of the cavity, temporaryfilling of cavities. J-Temp isindicated for temporaryrestorations. J-Temp is indicated forproviding structure for isolationclamping acting as a barrier forendodontic irrigants, because whencured it is harder than Clip Flow itcan be used in this specificprocedure as part of a temporaryfilling. Because J-Temp is harderwhen cured it can be indicated forsplinting between implant copingsfor impressions to resist impressionmaterial distortion, like thereference device Venus Flow whichhas an indication to splint teeth. J-Temp can also be indicated for Biteramps and temporary occlusalbuildups during orthodontics like
			combination with a suitablebonding agent; Splintingteeth ; Cavity lining;Bracket retention; Sealingendodontically treatedteeth; Luting porcelain orcomposite veneers; Fillingin voids in temporary crownand bridges materials		the reference device TKOComposite Bite Turbo Gel.
Intended User	Licensed Dentist orDental Professional	Licensed Dentist orDental Professional	Licensed Dentist or DentalProfessional	DentalProfessional	Same intended user. No identifieddifferences.
Characteristics	• Flowable, light-cured temporaryrestorativematerial.• Elastic consistencyand removable withprobe.	• Flowable, light-cured temporaryrestorativematerial.• Cured resinremovable withdental bur.	• Flowable, light-curedrestorative material.	• Flowable,light-curedcomposite Gel	Clip Flow and J-Temp are flowablelight-cured temporary restorativematerials. They are both intendedto be easily removed as temporarymaterials unlike the referencedevices.
Composition	• Methacrylates• Light cure initiatorsBHT	• Methacrylates• Light cure initiators• Glass ionomer fillersPigments	• Methacrylates• Light cure initiators• Barium Aluminum BoroFluor Silicate fillers• Pigments• BHT	• Methacrylates• Light cureinitiatorsPigments	Clip Flow and TKO Composite BiteTurbo Gel don't have fillers.Rationale for differences: J-Tempand Venus Flow have indications foruse that require a harder material.J-Temp doesn't need BHT which isfree radical inhibitor.
Delivery Systemor DeploymentMethods	Product is provided ina 1.8g syringe withdisposable deliverytips	Product is provided ina 1.2mL syringe withdisposable deliverytips	Product is provided in a1.8g syringe	Product isprovided in aprecision 3.5 gmLuerLoc syringewith tips	Clip Flow and the J-Temp areprovided in similar delivery syringesalong with the reference devices.
PhysicalProperties	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 thanClip Flow. J-Temp has a hardnessvalue comparable to TKOComposite Bite Turbo Gel. J-Temp'sflexural strength is less than VenusFlow and to TKO Composite BiteTurbo Gel. J-Temp is radio-opaque,and Clip Flow is not radio-opaque.
PatientPopulation	is suitable for use in allpatients without anyage or genderrestrictions	Individuals of all agesand gender and shallbe assessed by theadministering dentalprofessional.	The dental material issuitable for patientsrequiring dental treatmentfor the indications	Individualsreceivingorthodontictreatment.	N/A
			with consideration of thecontraindications.
Biocompatibilityand Safety	Biocompatible	Tested per ISO 7405,ISO 10993-1•Physical/ChemicalInformation•Systemic Toxicity•Genotoxicity•Cytotoxicity•Sensitization•Irritation•Implantation Effects	Biocompatible	ISO 10993-5ISO 7405:2018	The Clip Flow and J-Temp areshown to be biocompatible as wellas 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.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.