Transcend is a light cured, tooth shade resin composite material (Bis-GMA based) to be used for posterior and anterior tooth restorations. Transcend is radiopaque and available in a range of dentin, enamel, and body shades. It is 81% filled by weight and 58% filled by volume and has an average particle size of 0.9μm (by weight) with narrow upper limit particle distribution.

Composite Wetting Resin is a 45% filled, radiopaque light cured wetting resin. Composite Wetting Resin helps to improve the glide of the instrument during and contouring. It may be used during the placement of composite if the composite has become dry during incremental layering, or if the oxygen inhibition layer has been removed or disturbed. The wetting agent is an accessory and, if necessary, is used in conjunction with Transcend.

AI/ML Overview

This is a medical device 510(k) summary for a dental restorative material, not data from a study that fits the requested format for acceptance criteria of an AI/ML device. Therefore, the requested information elements such as sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, and ground truth establishment for training and test sets are not applicable or provided in this document content.

The provided text describes a "Transcend" tooth shade resin material and an accessory "Composite Wetting Resin." The document states that "before marketing the device, testing has been conducted to meet specified acceptance criteria." However, it does not provide specific numerical acceptance criteria or the reported device performance in a tabular format that is clearly tied to meeting those criteria, as typically seen for AI/ML device performance studies.

Instead, the document primarily focuses on demonstrating substantial equivalence to a predicate device (Amelogen Plus) and reference device (SeamFree) through comparisons of technological characteristics, intended use, composition, delivery systems, physical properties, shelf life, and adherence to relevant ISO and ADA standards.

Here's an attempt to extract relevant information, acknowledging that it doesn't align with the typical structure for AI/ML device performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device was tested against standards, and the results were within acceptable limits. It does not provide specific numerical acceptance criteria or reported values for each property.

Characteristic	Acceptance Criteria (based on standards)	Reported Device Performance
Flexural Strength	Conforms to ISO 4049 and ADA No. 27	Conforms to ISO 4049 and ADA No. 27
Depth of Cure	Conforms to ISO 4049 and ADA No. 27	Conforms to ISO 4049 and ADA No. 27
Water Sorption	Conforms to ISO 4049 and ADA No. 27	Conforms to ISO 4049 and ADA No. 27
Water Solubility	Conforms to ISO 4049 and ADA No. 27	Conforms to ISO 4049 and ADA No. 27
Ambient Light Sensitivity	Conforms to ISO 4049 and ADA No. 27	Conforms to ISO 4049 and ADA No. 27
Radiopacity	Conforms to ISO 4049 and ADA No. 27	Conforms to ISO 4049 and ADA No. 27
Color Stability	Conforms to ISO 4049 and ADA No. 27	Conforms to ISO 4049 and ADA No. 27
Biocompatibility	Passing results for various endpoints (Cytotoxicity, Sensitization, Irritation, etc.)	Passing results for each device and endpoint (Transcend & Composite Wetting Resin)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. Standard testing for material properties typically involves multiple samples for reproducibility, but the exact number is not detailed in this summary.
Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer or a third-party testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. This is not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is adherence to established material science standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not provided. The compliance is against defined material property standards, not subjective clinical assessments requiring adjudication.

5. 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 material, not an AI/ML diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a dental material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in this context is defined by the requirements of the standards: ISO 4049:2019 (Dentistry – Polymer-based restorative materials) and ANSI ADA 27-2016 (Polymer-based Restorative Materials) for physical properties, and ISO 10993-1:2018 for biocompatibility.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. This is not an AI/ML device.

Summary

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September 28, 2020

Ultradent Product, Inc. Karen Kakunes Director Regulatory Affairs 505 West Ultradent Drive (10200 South) South Jordan, Utah 84095

Re: K201795

Trade/Device Name: Transcend Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 29, 2020 Received: June 30, 2020

Dear Karen Kakunes:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

For Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K201795

Device Name Transcend

Indications for Use (Describe)

Transcend universal composite is used for direct restorations in both the anterior and posterior regions.

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

I. Applicant's Name and Address

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

Contact Person:	Ms. Karen Kakunes, RN, BSN
Title:	Director Regulatory Affairs
Telephone (cell):	801-673-1072
Fax:	801-553-4609
Email:	karen.kakunes@ultradent.com

Date Summary Prepared: September 28, 2020

II. Name of the Device

Trade Name:	Transcend
Common Name:	Tooth Shade Resin Material
Device Classification:	II
Classification Product Code:	EBF
Regulation No.	21 CFR 872.3690

III. Device Description

IV. Statement of Intended Use

Transcend universal composite is used for direct restorations in both the anterior and posterior regions.

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V. Predicate Device

The predicate device for Transcend, Amelogen Plus, is cleared under 510(k) K043119. The predicate device is also manufactured and distributed by Ultradent Products, Inc.

The reference device for the subject accessory device, Composite Wetting Resin is SeamFree, K092539, as manufactured by Apex Dental Materials.

VI. Comparison of Technological Characteristics

Predicate technological comparison:

The technology, delivery, and intended use of Transcend is substantially equivalent to the identified predicate. The technology, delivery, and intended use of the accessory device, Composite Wetting Resin, is similar to the reference device. Comparisons are outlined in Table 5-1.

Characteristic	Predicate ProductAmelogen Plus(K043119)	Subject Device:TranscendSubject Accessory Device:Composite Wetting Resin(K201795)	Reference DeviceSeamfree (K092539)	Difference
Indications forUse/IntendedUse	The Amelogen Plus is atooth shade resincomposite material[bisphenol-A, glycidylmethacrylate (Bis-GMA)based] to be used forposterior and anteriortooth restorations.	Transcend is used fordirect and indirectrestorations in both theanterior and posteriorregions.Composite Wetting Resinhelps to improve the glideof the instrument duringsculpting and contouring.It may be used during theplacement of composite ifthe composite has becomedry during incrementallayering, or if the oxygeninhibition layer has beenremoved or disturbed.	Seamfree is intended tobe used to lubricaterestorative instrumentsand materials. It can beused in all dentalrestorations and with anymethacrylate-basedmaterial.	SimilarThe Indications forUse of the subjectdevice is withinthat of thepredicate device.The indications foruse of the subjectaccessory device iswithin that of thereference device inthat it aids in theglide and lubricantof the instrumentand compositematerial.
Intended user	Licensed dentist	Licensed dentist	Licensed dentist	Identical
Composition ofMaterials	Methacrylate basedresin with FDA approvedpigments	Transcend:Methacrylate based resinwith FDA approvedpigments		Similar
	Bis-GMA, GDMAPhospate, TEGDMA,BHT, Camphorquinone,Ethyl-4-Dimethlyaminobenzoate, Barium borosilicateglass powder, AluminumOxide C	Bis-GMA, Ethoxylated (2)Bisphenol ADimethacrylate, HDDMA,HPMA, Camphorquinone,Ethyl-4-Dimethlyaminobenzoate,Omnirad 819, OPPI, CEMA,Glass fillers		Both the subjectdevice and thepredicate deviceconsist mainly offillers andmethacrylates.They each havesimilar resins andinitiators/inhibitorsfor appropriatecuring.
	FDA Approved pigmentsin varyingconcentrationsdepending on compositeshade: TiO2, Yellow IronOxide, Red Iron Oxide,Lumilux Blue, Black	FDA Approved Pigments invarying concentrationsdepending on compositeshade: TiO2, Yellow IronOxide, Red Iron Oxide,Lumilux Blue, Black		The subjectaccessory device issimilar in primarycomposition to thereference device inthat they are bothmethacrylate-based resins.
		Composite Wetting Resin:DUDMA, Bis-GMA,TEGDMA,Camphoquinone, Ethyl-4-dimethylaminobezoate,BHT, Aluminum Oxide,Barium Alumina SilicateGlass
Delivery system	Compule, syringe	Transcend: Compule,syringeComposite Wetting Resin:syringe	Bottle, Syringe	Identical betweensubject andpredicate device.Similar in thatsubject device isonly available insyringe wherereference device isa bottle and asyringe.
PhysicalpropertyFlexuralStrength	Conforms to therequirement of ISO 4049and ADA No. 27	Conforms to therequirement of ISO 4049and ADA No. 27	N/A	SimilarSlight differencesin property values,but both devicesconform to therequirements of

Depth of Cure	Conforms to therequirement of ISO 4049and ADA No. 27	Conforms to therequirement of ISO 4049and ADA No. 27		ISO 4049/ADA No.27
Water Sorption	Conforms to therequirement of ISO 4049and ADA No. 27	Conforms to therequirement of ISO 4049and ADA No. 27		The subjectaccessory device
Water Solubility	Conforms to therequirement of ISO 4049and ADA No. 27	Conforms to therequirement of ISO 4049and ADA No. 27		was tested withmethacrylate-based compositeand passedacceptancecriteria.
Ambient LightSensitivity	Conforms to therequirement of ISO 4049and ADA No. 27	Conforms to therequirement of ISO 4049and ADA No. 27
Radio - Opacity	Conforms to therequirement of ISO 4049and ADA No. 27	Conforms to therequirement of ISO 4049and ADA No. 27
Color Stability	Conforms to therequirement of ISO 4049and ADA No. 27	Conforms to therequirement of ISO 4049and ADA No. 27

Shelf Life	36 months @ 18-27°C	Transcend:	Unknown	Similar
		24 months @ 18-27°C		Subject device hasshorter shelf life to
		Composite Wetting Resin:		release to market
		40 months @ 2-8°C		as on-goingstability testing isperformed.Identical storagerequirements.

Standards	ISO 10993, ISO 14971,ANSI ADA Standard No.27-2016	Transcend: ISO 10993, ISO14971, ISO 4049:2019,ANSI ADA 27-2016	Not available	Identical betweensubject and

				predicate device.
		Composite Wetting Resin:ISO 10993, ISO 14971

Table 5-1: Substantial equivalence comparison

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The technological and performance characteristics of Transcend are very similar to those of the predicate device, Amelogen Plus (K043119). Transcend is a similar product, manufactured with similar or identical materials and used in the same way by the same types of users. The differences outlined above do not affect substantial equivalence.

In addition, the accessory device, Composite Wetting Resin, is similar in technology, used in the same way by the same users and with the same type of product(s) as the reference device, Seamfree (K092539).

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VI. Non-Clinical Performance Data Summary

Before marketing the device, testing has been conducted to meet specified acceptance criteria.

Transcend has been designed and tested to ISO 4049:2019 Dentistry – Polymer-based restorative materials and ANSI ADA 27-2016 Polymer-based Restorative Materials. Results for each property are within the acceptable limits of the identified standard(s).

Biocompatibility testing has been assessed for both the subject device and the subject accessory device according to ISO 10993-1:2018. The following tests were identified as appropriate for both Transcend and Composite Wetting Resin: Cytotoxicity, Sensitization, Irritation, Material Mediated Pyrogenicity, Systemic Toxicity, Local effects after implantation, Genotoxicity, and Carcinogenicity with passing results for each device and endpoint.

VII. Conclusion

The device design, delivery form(s) and intended use of Transcend and the accessory device, Composite Wetting Resin, are identical or very similar to that of the predicate and reference device(s). Based on the technological characteristics and performance testing, Ultradent Products, Inc. believes Transcend is substantially equivalent to Amelogen Plus.

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.