Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and biocompatibility of a dental composite and wetting resin, with no mention of AI or ML capabilities.

Therapeutic

No.
The device is a restorative material for direct filling of teeth, which is not considered a therapeutic device.

Diagnostic

No.
The device is a dental restorative material used for direct restorations, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "light cured, tooth shade resin composite material" and a "light cured wetting resin," which are physical materials, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "direct restorations in both the anterior and posterior regions" of teeth. This is a therapeutic and restorative use, not a diagnostic one.
Device Description: The device is a "light cured, tooth shade resin composite material" used for filling cavities. This is a material used on the body, not for testing samples from the body.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
Regulatory Standards: The device is tested to standards for "Polymer-based restorative materials," which are relevant to dental materials used for restoration, not diagnostic tests.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

EBF

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth (anterior and posterior regions)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Licensed dentist

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Non-Clinical Performance Data Summary:
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.

Key Metrics

Not Found

Predicate Device(s)

K043119

Reference Device(s)

K092539

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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

1

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

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
Amelogen Plus
(K043119) | Subject Device:
Transcend
Subject Accessory Device:
Composite Wetting Resin
(K201795) | Reference Device
Seamfree (K092539) | Difference |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use/Intended
Use | The Amelogen Plus is a
tooth shade resin
composite material
[bisphenol-A, glycidyl
methacrylate (Bis-GMA)
based] to be used for
posterior and anterior
tooth restorations. | Transcend is used for
direct and indirect
restorations in both the
anterior and posterior
regions.
Composite Wetting Resin
helps to improve the glide
of the instrument during
sculpting 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. | Seamfree is intended to
be used to lubricate
restorative instruments
and materials. It can be
used in all dental
restorations and with any
methacrylate-based
material. | Similar
The Indications for
Use of the subject
device is within
that of the
predicate device.
The indications for
use of the subject
accessory device is
within that of the
reference device in
that it aids in the
glide and lubricant
of the instrument
and composite
material. |
| Intended user | Licensed dentist | Licensed dentist | Licensed dentist | Identical |
| Composition of
Materials | Methacrylate based
resin with FDA approved
pigments | Transcend:
Methacrylate based resin
with FDA approved
pigments | | Similar |
| | Bis-GMA, GDMA
Phospate, TEGDMA,
BHT, Camphorquinone,
Ethyl-4-
Dimethlyaminobenzoate
, Barium borosilicate
glass powder, Aluminum
Oxide C | Bis-GMA, Ethoxylated (2)
Bisphenol A
Dimethacrylate, HDDMA,
HPMA, Camphorquinone,
Ethyl-4-
Dimethlyaminobenzoate,
Omnirad 819, OPPI, CEMA,
Glass fillers | | Both the subject
device and the
predicate device
consist mainly of
fillers and
methacrylates.
They each have
similar resins and
initiators/inhibitors
for appropriate
curing. |
| | FDA Approved pigments
in varying
concentrations
depending on composite
shade: TiO2, Yellow Iron
Oxide, Red Iron Oxide,
Lumilux Blue, Black | FDA Approved Pigments in
varying concentrations
depending on composite
shade: TiO2, Yellow Iron
Oxide, Red Iron Oxide,
Lumilux Blue, Black | | The subject
accessory device is
similar in primary
composition to the
reference device in
that they are both
methacrylate-
based resins. |
| | | Composite Wetting Resin:

DUDMA, Bis-GMA,
TEGDMA,
Camphoquinone, Ethyl-4-
dimethylaminobezoate,
BHT, Aluminum Oxide,
Barium Alumina Silicate
Glass | | |
| Delivery system | Compule, syringe | Transcend: Compule,
syringe

Composite Wetting Resin:
syringe | Bottle, Syringe | Identical between
subject and
predicate device.

Table 5-1: Substantial equivalence comparison

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6

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.