UltraSeal XT® hydro is a 53% filled, light cure, radiopaque, methacrylatebased, thixotropic resin sealant. It is hydrophyllic and has a self-adhesive quality. UltraSeal XT® hydro™ chemistry provides the option of a visual verification for marginal retention with the use of a UV light, upon placement and at recall visits. The UV light is not included in the Ultra Seal XT® hydro™ kit.

AI/ML Overview

The provided text describes a Special 510(k) premarket summary for a dental device called UltraSeal XT® hydro™. The document focuses on establishing substantial equivalence to predicate devices and detailing the technological characteristics and performance testing of the new device. However, it does not contain the kind of information typically found in a study proving a device meets acceptance criteria, particularly in the context of AI/ML-based medical devices as implied by your request.

Specifically, the document does not include:

A table of acceptance criteria and reported device performance in the format you requested, nor does it specify numerical performance targets.
Mention of a "test set" with sample size, data provenance, or ground truth establishment.
Information about experts, adjudication methods, or multi-reader multi-case (MRMC) comparative effectiveness studies.
Details on standalone algorithm performance or training set characteristics (sample size, ground truth).

The text describes various physical and chemical property tests performed on the dental sealant to demonstrate its performance and establish an 18-month shelf life. These are standard tests for material science and dental products, not for AI/ML algorithms.

Here's a breakdown of what is available in the document, framed against your request, while highlighting what's missing:

Acceptance Criteria and Study to Prove Device Meets Criteria:

1. A table of acceptance criteria and the reported device performance

The document lists several tests performed, implying that certain performance thresholds were met for each, but it does not provide numerical acceptance criteria or specific reported performance values in a table for UltraSeal XT® hydro™. Instead, it gives qualitative statements about the desired outcomes of the tests in comparison to predicate devices.

Qualitative Performance Claims (Implied Acceptance):

Test	Acceptance Criteria (Implied)	Reported Device Performance (Qualitative)
Shear Bond	High MPa value (adhesion to tooth)	"This is the most impressive test to show that UltraSeal XT® hydro™ provides the highest adhesion to the tooth compared to both of our predicates. This adhesion is accomplished without the use of a drying agent... This test shows that UltraSeal XT® hydro™ will bond well to the tooth creating a very successful pit and fissure sealant."
Flexural Strength	Higher than competitors, more "give" (elasticity)	"This test will show the strength of the bond during stress. A higher number than our competitors is good. The modulus side of this test shows the strength at which flexing the bond occurs. Our testing shows more 'give' to it as our competitor's product tends to be 'stiffer.' We prefer the elasticity as it allows the product to remain on the teeth longer and 'gives' with movement."
Hardness	Higher than competitors	"This test shows the resiliency of the material to resist deformation. It is acceptable for us to remain higher than our competitors."
Ambient Light Working Time	Product sets up quickly for reduced chair time	"This test shows the time that the product will cure in ambient light. It shows working time with the product and curing time of the product. We prefer the product to set up quickly to reduce chair time for the dentist and patient."
Sorption	Low readings (resin absorbs less water)	"This test shows how much water the resin absorbs. We want low readings on this test."
Uncured Film thickness	Defined thickness (implies successful bonding)	Tested (no qualitative performance stated, just that the test was done for bond strength)
Solubility	Low number (product does not degrade in solutions/saliva)	"Look for a low g. number on this test."
Compressive Strength	Higher number (material resists breaking under compression)	"Measures the material's ability to not break apart under a compressive load. Prefer a higher number."
Shrinkage Stress	High strength adhesion (implies low shrinkage stress)	"This test determines shrinkage over a specified period of time. This value shows the high strength adhesion of the product."
Shrinkage %	Low value	"This test determines how much shrinkage will occur when the product has fully cured. We prefer a low value on shrinkage."
Depth of Cure	Shows light cure ability	"This test shows the light cure ability of the product."
Joules Test - Setting Time	Cures in 3 seconds time (specific joules)	"This test shows actual joules to cure the product in 3 seconds time."
Shelf Life	18 months	"Stability testing was conducted on UltraSeal XT® hydro™ and the results show that the product has an 18 month shelf life based on accelerated stability studies conducted in R & D." (Accelerated study equiv. to 19.5 months real time)

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

This information is not provided in the document. The tests described are laboratory-based material property tests, not clinical performance studies with patient data.

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)

This information is not provided as the device is a physical dental sealant, not an AI/ML algorithm requiring expert interpretation of medical images.

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

This information is not provided. Not applicable for physical material tests.

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

Such a study was not performed or mentioned. This is a material science product, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is a physical pit and fissure sealant, not a software algorithm.

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

"Ground truth" as understood in AI/ML is not applicable here. The "truth" for material properties is established through standardized physical and chemical testing methods (e.g., measuring shear bond strength in MPa).

8. The sample size for the training set

This is not applicable as the device does not employ a training set (it is not an AI/ML device).

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

This is not applicable.

Summary

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s KII2517

SPECIAL 510(K) PREMARKET SUMMARY

SEP 2 3 2011

UltraSeal XT® hydro™

This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for UltraSeal XT® hydro™.

Applicant's Name and Address

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

Contact Person: Diane Rogers Title: Manager of Regulatory and International Affairs Telephone: (800) 552-5512 x4491, (801) 553-4491 FAX: (801) 553-4609 Date Summary Prepared: August 16, 2011

Name of the Device

Trade Name: Common Name:

Regulation Number: Device Classification: Classification Product Code: UltraSeal XT® hvdro™ Pit and Fissure Sealant and Conditioner CFR 872.3765 ll EBC

Legally Marketed Predicate Device to Which Equivalence is Claimed

The first predicate device is: UltraTemp XT® plus (K993846). This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095. The second predicate device is Embrace™ Wet Bond™ (K052281) manufactured and distributed by Pulpdent Corporation 80 Oakland Street, Watertown, Massachusetts 02472.

ﻨﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺘﻮﻗﻒ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

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Description: UltraSeal XT® hydro is a 53% filled, light cure, radiopaque, methacrylatebased, thixotropic resin sealant. It is hydrophyllic and has a self-adhesive quality. UltraSeal XT® hydro™ chemistry provides the option of a visual verification for marginal retention with the use of a UV light, upon placement and at recall visits. The UV light is not included in the Ultra Seal XT® hydro™ kit.

Indications for Use: Use Ultra Seal XT® hydro™ for prophylactic sealing of pits and fissures.

	UltraSeal XT® hydro™	UltraSeal XT® plus(K993846)	Pulpdent Embrace™Wet Bond™(K052281).
IndicationsFor Use	Use UltraSeal XT® hydro™ forprophylactic sealing of pits andfissures	Use UltraSeal XT®plus for prophylacticsealing of pits andfissures. It may alsobe used formicrorestorative or"initial layer" ofcompositerestorations.	Embrace™ Wet Bond™Clear Sealant is ahydrophyllic, light-cured materialrecommended for useas a pit and fissuresealant. Embrace™WetBond™ ClearSealant may be usedto seal small defectssuch as buccal pits,lingual grooves orfacial surface defects.Embrace™ WetBond™Clear Sealant may alsobe used as anorthodontic bracketcoating. Embrace™WetBond™ ClearSealant hardens/curessuch that the materialis clear.
DeliverySystem	Syringe	Syringe	Syringe

Comparison Table

Special 510(k) for UltraSeal XT® hydro™

Ultradent Products, Inc.

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Ultradent decided to reduce the claims of microrestorative or "initial layer" of composite restorations on UltraSeal XT® hydro™ as the product was specifically designed to simply be the best pit and fissure sealant on the market.

Technological Characteristics: UltraSeal XT® hydro is a 53% filled, light cure, radiopaque, methacrylate-based, thixotropic resin sealant. It is hydrophyllic and has a self-adhesive quality. UltraSeal XT® hydro™ chemistry provides the option of a visual verification for marginal retention with the use of a UV light, upon placement and at recall visits. The UV light is not included in the Ultra Seal XT® hydro™ kit.

The unique chemistry of UltraSeal XT® hydro™ has eliminated the need to use PrimaDry (K931868) manufactured by Ultradent Products Inc., 505 West 10200 South, South Jordan, Utah 84095 or any other drying products prior to resin placement to eliminate moisture.

Brief Description of Testing Performed

Detailed test reports are located in the Design Control Section of this 510(k)

Stability Testing for Shelf Life

Stability testing was conducted on UltraSeal XT® hydro™ and the results show that the product has an 18 month shelf life based on accelerated stability studies conducted in R & D. The timing of seven weeks of storage at a temperature elevated 36°C above ambient is equivalent to 84.9 weeks or 19.5 months of real time shelf life.

a. Shear Bond This is the most impressive test to show that UltraSeal XT® hydro™ provides the highest adhesion to the tooth compared to both of our predicates. This adhesion is accomplished without the use of a drying agent such as PrimaDry (K931868). A high MPa value is preferred as it shows that the product will remain on the tooth, protecting it longer than a product with a lower Shear Bond Strength. This test shows that UltraSeal XT® hydro™ will bond well to the tooth creating a very successful pit and fissure sealant.
b. Flexural Strength This test will show the strength of the bond during stress. A higher number than our competitors is good. The modulus side of this test shows the strength at which flexing the bond occurs. Our testing shows more "give" to it as our competitor's product tends to be "stiffer. We prefer the elasticity as it allows the product to remain on the teeth longer and "gives" with movement.
Hardness This test shows the resiliency of the material to resist deformation. It is ﻥ acceptable for us to remain higher than our competitors.

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d. Ambient Light Working Time This test shows the time that the product will cure in ambient light. It shows working time with the product and curing time of the product. We prefer the product to set up quickly to reduce chair time for the dentist and patient.
e. Sorption This test shows how much water the resin absorbs. We want low readings on this test.
f. Uncured Film thickness - testing bond strength at a defined thickness.
Soluability- testing whether the product degrades in solutions or saliva. Look for a low g. number on this test.
h. Compressive Strength - Measures the material's ability to not break apart under a compressive load. Prefer a higher number.
i. Shrinkage Stress - This test determines shrinkage over a specified period of time. This value shows the high strength adhesion of the product.
j. Shrinkage % - This test determines how much shrinkage will occur when the product has fully cured. We prefer a low value on shrinkage.
k. Depth of Cure This test shows the light cure ability of the product.
1. Joules Test - Setting Time - This test shows actual joules to cure the product in 3 seconds time.

Special 510(k) for UltraSeal XT® hydro™

Ultradent Products, Inc.

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its wing, representing the department's mission to protect the health of all Americans and provide essential human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

SEP 2 3 2011

Re: K112517

Trade/Device Name: UltraSeal XT™ hydro"" Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: August 16, 2011 Received: August 31, 2011

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 Cosmotic 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 Federal 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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /uom115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Statement of Indications for Use

K 1125 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Use UltraSeal XT® hydro™ for prophylactic sealing of pits and fissures.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Posted November 13, 2003)

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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112577

Special 510(k) for UltraSeal XT® hydro™

Ultradent Products, Inc.

Regulation Number and Section

§ 872.3765 Pit and fissure sealant and conditioner.

(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.