UltraCem™ is indicated for cementation of indirect restorations (including inlays, onlays, crowns and bridges) made of metal, porcelain fused to metal, zirconia, and resin to natural teeth. This product is also intended for cementation of orthodontic bands to natural teeth.

Device Description

UltraCem™ is a chemical cure, resin reinforced (modified) glass ionomer cement. UltraCem™ is supplied in a pre-mixed syringe for easy delivery and no waste, and also in two part bottles to be mixed with application brushes then directly applied to surfaces.

AI/ML Overview

The provided text describes a 510(k) submission for the dental cement UltraCem™ and primarily focuses on demonstrating its substantial equivalence to a predicate device, K111855 Hy-Bond Resiglass. The study presented is a bench testing comparison, not a clinical study involving human patients or complex AI algorithms. Therefore, much of the requested information regarding AI performance, human readers, ground truth for training sets, etc., is not applicable to this document.

Here's the breakdown of the information that can be extracted and a clear indication of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each performance metric. Instead, it states that UltraCem™ is "comparable to Hy-Bond" or that "test results indicate that UltraCem™ is substantially equivalent to the predicate device." The detailed numerical results from "Section 18 Bench Testing" are not included in the provided text.

Performance Metric	Acceptance Criteria (Not explicitly stated as numerical, but implied as "comparable to predicate")	Reported Device Performance (Summary)
Shear Bond	Implied: Comparable bonding enhancement to various surfaces as the predicate device (Hy-Bond system).	"UltraCem™ is comparable to Hy-Bond which is currently on the market and is well-received." (Detailed in-vitro test results from Section 18 not provided).
Working-Setting Time	Implied: Performance within an acceptable range for dental cement application, comparable to predicate. (Specific criteria and predicate values not provided).	Working time: "when the product began to display gel-like polymerization properties." Setting time: "when the product was polymerized to the point when the mass could be moved as a whole." (Specific times from Section 18 not provided).
Film Thickness	Implied: Acceptable film thickness for dental cement applications, comparable to predicate. (Specific criteria not provided).	Measured in microns. (Specific values from Section 18 not provided).
Flexural Strength	Implied: Sufficient flexural strength for indirect restorations, comparable to predicate. (Specific criteria not provided).	"Strengths were recorded." (Specific values from Section 18 not provided).
Radiopacity	Implied: Sufficient visibility under X-ray, comparable to predicate. (Specific criteria not provided).	"Compared to determine how well the products can be viewed in an X-Ray." (Specific comparison results from Section 18 not provided).
Biocompatibility	Not performed. Acceptance criterion is based on the predicate device's prior testing: "the same exact formula and ingredients" as the predicate device, which was tested for Cytotoxicity, Sensitization, Irritation, and Genotoxicity according to ISO 10993-1. (This serves as the "acceptance" for UltraCem™ not requiring its own separate biocompatibility study).	Biocompatibility was not performed for UltraCem™ because its formula is identical to the predicate device (K111855 Hy-Bond Resiglass), which was previously tested and found compliant with ISO 10993 (Cytotoxicity, Sensitization, Irritation, Genotoxicity).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated for each bench test. The document refers to "samples were prepared," "specimens were allowed to cure," but no specific numbers.
Data Provenance: The bench tests were "in-house testing," implying the data was generated by Ultradent Products, Inc. The exact country of origin for the data generation and whether it was retrospective or prospective is not detailed, but "in-house testing" strongly suggests prospective lab testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This study involves bench testing of physical properties of a dental cement, not clinical image analysis or expert review requiring ground truth established by medical experts for diagnostic purposes. The expertise would likely be in materials science and dental product testing.

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

Not Applicable. As this is a bench testing study comparing physical properties, there is no expert adjudication method like those used for clinical readings or diagnostic AI algorithms. The results would be objectively measured.

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 document describes a traditional 510(k) for a dental cement, involving bench tests. There is no mention or implication of AI or human readers, so an MRMC study or effect size related to AI assistance is irrelevant here.

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

Not Applicable. There is no algorithm or AI component in this device described in the submission. It is a material-based dental cement.

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

Bench Test Measurements/Predicate Device Comparison: For the physical tests (shear bond, working/setting time, film thickness, flexural strength, radiopacity), the "ground truth" would be the objective measurements obtained in the lab. For substantial equivalence, the performance of UltraCem™ is compared directly to the measured performance of the legally marketed predicate device, K111855 Hy-Bond Resiglass, which effectively serves as the benchmark or "ground truth" for acceptable performance. For biocompatibility, the "ground truth" for not needing direct testing was the identical formulation to the predicate, which had approved ISO 10993 results.

8. The sample size for the training set

Not Applicable. There is no AI component or machine learning model that would require a training set in this submission.

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

Not Applicable. As there is no training set, there is no ground truth for a training set to be established.

Summary

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OCT 2 4 2013

Section 5

Traditional 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.

Applicant's Name and Address

Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095

Contact Person: Title: Telephone: FAX: Date Summary Prepared:

Diane Rogers Manager of Regulatory and Global Affairs (800) 552-5512 x4491, (801) 553-4491 (801) 553-4609 July 18, 2013

Name of the Device

UltraCem™ Trade Name: Dental Cement Common Name: Device Classification: Class II Classification Product Code: EMA

Legally Marketed Predicate Devices to Which Equivalence is Claimed

The predicate device is: K111855 Hy-Bond Resiglass by Shofu dental of San Marcos, CA 92078

UltraCem™ is very similar to our predicate device in that both devices are intended to be used as dental cements.

Indications for Use: UltraCem™ is indicated for cementation of indirect restorations (including inlays, onlays, crowns and bridges) made of metal, porcelain fused to metal, zirconia, and resin to natural teeth. This product is also intended for cementation of orthodontic bands to natural teeth.

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Product Description: UltraCem™ is a chemical cure, resin reinforced (modified) glass ionomer cement.

Technological characteristics

UltraCem™		UltraCem™ is indicated forcementation of indirectrestorations (including inlays,onlays, crowns and bridges)made of metal, porcelainfused to metal, zirconia, andresin to natural teeth. Thisproduct is also intended forcementation of orthodonticbands to natural teeth.
Hy-Bond Resiglass	111855	Hy-Bond Resiglass isintended forcementation ofrestorations (includinginlay, crown andbridge) made of metal,ceramics (porcelain)and resin to naturalteeth. This product isalso intended forcementation oforthodontic appliances(metal bracket,ceramic bracket, etc)to natural teeth.
Characteristics	Glass ionomer cement	Glass ionomer cement
Human Factors	Syringe delivery or brush andbottle	Brush and bottle
Biocompatibility	Not performed as the formulais the same as our predicateand then the product isplaced in our own syringedelivery system, or used inbottles	ISO 10993CytotoxicitySensitizationIrritationGenotoxicity

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UltraCem™ is supplied in a pre-mixed syringe for easy delivery and no waste, and also in two part bottles to be mixed with application brushes then directly applied to surfaces.

Hy-Bond Resiglass is supplied in two part bottles to be mixed with application brushes then directly applied to surfaces.

The patient population is intended for all ages that need a restoration or repair as prescribed by a dentist. UltraCem™ is a chemical cure, resin reinforced (modified) glass ionomer cement.

Brief Description of Testing Performed

The following bench tests were conducted during the R & D phase on UltraCem™ and compared to K111855 Hy-Bond Resiglass. Final test results are in Section 18 "Bench Testing".

Shear bond: This in-vitro test determines how well the material enhances the bonding to various surfaces compared to both the Hy-Bond system and the UltraCem™ system. UltraCem™ is comparable to Hy-Bond which is currently on the market and is well-received.

Working-Setting Time: The working time was determined to be when the product began to display gel-like polymerization properties. The setting time was determined to be the time when the product was polymerized to the point when the mass could be moved as a whole.

Film Thickness: A micrometer was zeroed on two glass cover slips. A small drop of product was placed between the cover slips, which were then placed underneath a load for several seconds. The thickness was measured in microns and recorded.

Flexural Strength: Samples were prepared with each product and allowed to cure, then stored in 40° water for 24 hours. The samples were tested and the strengths were recorded.

Radiopacity: Specimens were allowed to cure then placed under an X-Ray machine and compared to determine how well the products can be viewed in an X-Ray.

Clinical Summary

A complete Clinical Summary of UltraCem™ is included in Section 20. We conducted a literature study to show substantial equivalence in safety and effectiveness of this product. The product can be used on any age patient when treatment is prescribed by a dentist. The device has the same technological characteristics compared to K111855 Hy-Bond Resiglass by Shofu dental of San Marcos, CA 92078.

Hy-Bond Resiglass has been widely used by numerous dentists in the dental industry.

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The intended purpose of UltraCem™ has been demonstrated by a combination of in-house testing and side-by-side comparisons to a predicate device currently on the market. Results of our bench testing indicates that UltraCem™ is substantially equivalent to the predicate device currently on the market. (Test results are in Section 18 Bench Testing).

Summary Risk/Benefit Review

Considering the safe history of our predicate, K111855 Hy-Bond Resiglass by Shofu dental of San Marcos, CA 92078 UltraCem™ is substantially equivalent to our predicate device. Our research indicates that our predicate has been used by many dentists and large group practices in the United States and purchased by a large number of international distributors. To date, there have been no reported complaints of local or systemic adverse effects associated with the use of the predicate product.

UltraCem™ was not tested for biocompatibility as our predicate (K111855) has the same exact formula and ingredients and their product was tested in Cytotoxicity, Sensitization, Irritation and Genotoxicity tests according to ISO 10993-1.

In conclusion, UltraCem™ has been designed and manufactured with the intended use and claims for the product in mind. Scientific literature, etc. has been collected and determined to be substantially equivalent in safety and effectiveness of similar products used for the same indication. Following the clinical review as documented above, Ultradent Products, Inc. deems that when this device is used under the conditions and for the purposes intended, it will not compromise the clinical condition and the association with its use constitutes acceptable risks when weighed against the benefits to the patient. Therefore, the product is substantially equivalent and may be released to the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 24, 2013

Ultradent Products, Incorporated C/O Ms. Diane Rogers Regulatory and Global Affairs Manager 505 West 10200 South South Jordan, Utah 84095

Re: K132255

Trade/Device Name: UltraCem™ Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA. DYH Dated: August 8, 2013 Received: August 9, 2013

Dear Ms. Rogers:

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. 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 Eederal Register.

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Page 2 - Ms. Rogers

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K132255

Page 18 of 492

Statement of Indications for Use

510(k) Number (if known): __

Device Name: UltraCem™

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page ___ of _1

Mary S. Runner -S
Susan Runner DDS, PA 2013.10.24
11:07:08 -04'00'

(Posted November 13, 2003)

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.