Transcend

K201795 · Ultradent Product, Inc. · EBF · Sep 28, 2020 · Dental

Device Facts

• Record ID: K201795
• Device Name: Transcend
• Applicant: Ultradent Product, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 28, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Transcend is a light-cured, radiopaque, Bis-GMA-based resin composite for anterior and posterior tooth restorations. It is 81% filled by weight (58% by volume) with 0.9μm average particle size. Used by licensed dentists in clinical settings. The device is applied via syringe or compule. An accessory, Composite Wetting Resin (45% filled), is used to improve instrument glide and contouring during placement if the composite dries or the oxygen inhibition layer is disturbed. The clinician uses the material to fill cavities; light curing hardens the resin. Benefits include restoration of tooth structure and aesthetics.

Clinical Evidence

Bench testing only. Transcend and the accessory wetting resin were tested for physical properties per ISO 4049:2019 and ANSI ADA 27-2016, including flexural strength, depth of cure, water sorption, water solubility, ambient light sensitivity, radiopacity, and color stability. Biocompatibility was assessed per ISO 10993-1:2018, including cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, systemic toxicity, local effects after implantation, genotoxicity, and carcinogenicity. All tests met acceptance criteria.

Technological Characteristics

Methacrylate-based resin composite (Bis-GMA, Ethoxylated Bisphenol A Dimethacrylate, HDDMA, HPMA). Fillers: Glass fillers (81% wt, 58% vol). Initiators/Inhibitors: Camphorquinone, Ethyl-4-Dimethylaminobenzoate, Omnirad 819, OPPI, CEMA. Radiopaque. Delivery: Syringe or compule. Standards: ISO 4049:2019, ANSI ADA 27-2016, ISO 10993, ISO 14971. Accessory: Composite Wetting Resin (DUDMA, Bis-GMA, TEGDMA, BHT, Aluminum Oxide, Barium Alumina Silicate Glass).

Indications for Use

Indicated for direct restorations in anterior and posterior regions in patients requiring dental composite restorative material.

Regulatory Classification

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.

Predicate Devices

• Amelogen Plus (K043119)

Reference Devices

• SeamFree (K092539)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | 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: | [e-mail] |
| | |

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

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.

### 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 Product<br>Amelogen Plus<br>(K043119) | Subject Device:<br>Transcend<br>Subject Accessory Device:<br>Composite Wetting Resin<br>(K201795) | Reference Device<br>Seamfree (K092539) | Difference |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use/Intended<br>Use | The Amelogen Plus is a<br>tooth shade resin<br>composite material<br>[bisphenol-A, glycidyl<br>methacrylate (Bis-GMA)<br>based] to be used for<br>posterior and anterior<br>tooth restorations. | Transcend is used for<br>direct and indirect<br>restorations in both the<br>anterior and posterior<br>regions.<br>Composite Wetting Resin<br>helps to improve the glide<br>of the instrument during<br>sculpting and contouring.<br>It may be used during the<br>placement of composite if<br>the composite has become<br>dry during incremental<br>layering, or if the oxygen<br>inhibition layer has been<br>removed or disturbed. | Seamfree is intended to<br>be used to lubricate<br>restorative instruments<br>and materials. It can be<br>used in all dental<br>restorations and with any<br>methacrylate-based<br>material. | Similar<br>The Indications for<br>Use of the subject<br>device is within<br>that of the<br>predicate device.<br>The indications for<br>use of the subject<br>accessory device is<br>within that of the<br>reference device in<br>that it aids in the<br>glide and lubricant<br>of the instrument<br>and composite<br>material. |
| Intended user | Licensed dentist | Licensed dentist | Licensed dentist | Identical |
| Composition of<br>Materials | Methacrylate based<br>resin with FDA approved<br>pigments | Transcend:<br>Methacrylate based resin<br>with FDA approved<br>pigments | | Similar |
| | Bis-GMA, GDMA<br>Phospate, TEGDMA,<br>BHT, Camphorquinone,<br>Ethyl-4-<br>Dimethlyaminobenzoate<br>, Barium borosilicate<br>glass powder, Aluminum<br>Oxide C | Bis-GMA, Ethoxylated (2)<br>Bisphenol A<br>Dimethacrylate, HDDMA,<br>HPMA, Camphorquinone,<br>Ethyl-4-<br>Dimethlyaminobenzoate,<br>Omnirad 819, OPPI, CEMA,<br>Glass fillers | | Both the subject<br>device and the<br>predicate device<br>consist mainly of<br>fillers and<br>methacrylates.<br>They each have<br>similar resins and<br>initiators/inhibitors<br>for appropriate<br>curing. |
| | FDA Approved pigments<br>in varying<br>concentrations<br>depending on composite<br>shade: TiO2, Yellow Iron<br>Oxide, Red Iron Oxide,<br>Lumilux Blue, Black | FDA Approved Pigments in<br>varying concentrations<br>depending on composite<br>shade: TiO2, Yellow Iron<br>Oxide, Red Iron Oxide,<br>Lumilux Blue, Black | | The subject<br>accessory device is<br>similar in primary<br>composition to the<br>reference device in<br>that they are both<br>methacrylate-<br>based resins. |
| | | Composite Wetting Resin:<br><br>DUDMA, Bis-GMA,<br>TEGDMA,<br>Camphoquinone, Ethyl-4-<br>dimethylaminobezoate,<br>BHT, Aluminum Oxide,<br>Barium Alumina Silicate<br>Glass | | |
| Delivery system | Compule, syringe | Transcend: Compule,<br>syringe<br><br>Composite Wetting Resin:<br>syringe | Bottle, Syringe | Identical between<br>subject and<br>predicate device.<br><br>Similar in that<br>subject device is<br>only available in<br>syringe where<br>reference device is<br>a bottle and a<br>syringe. |
| Physical<br>property<br>Flexural<br>Strength | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | N/A | Similar<br>Slight differences<br>in property values,<br>but both devices<br>conform to the<br>requirements of |
| | | | | |
| Depth of Cure | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | | ISO 4049/ADA No.<br>27 |
| Water Sorption | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | | The subject<br>accessory device |
| Water Solubility | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | | was tested with<br>methacrylate-<br>based composite<br>and passed<br>acceptance<br>criteria. |
| Ambient Light<br>Sensitivity | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | | |
| Radio - Opacity | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | | |
| Color Stability | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | Conforms to the<br>requirement of ISO 4049<br>and ADA No. 27 | | |
| | | | | |
| Shelf Life | 36 months @ 18-27°C | Transcend: | Unknown | Similar |
| | | 24 months @ 18-27°C | | Subject device has<br>shorter shelf life to |
| | | Composite Wetting Resin: | | release to market |
| | | 40 months @ 2-8°C | | as on-going<br>stability testing is<br>performed.<br>Identical storage<br>requirements. |
| | | | | |
| Standards | ISO 10993, ISO 14971,<br>ANSI ADA Standard No.<br>27-2016 | Transcend: ISO 10993, ISO<br>14971, ISO 4049:2019,<br>ANSI ADA 27-2016 | Not available | Identical between<br>subject and |
| | | | | |
| | | | | predicate device. |
| | | Composite Wetting Resin:<br>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.