Use UltraSeal ID for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations.

Device Description

UltraSeal ID is a 58% filled, light-cure, radiopaque, methacrylate-based, thixitropic resin sealant. UltraSeal ID technology provides visual verification for marginal retention with the use of a UV light, upon placement and at recall visits. 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental pit and fissure sealant called UltraSeal ID. This document describes the device and its equivalence to existing predicate devices, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared devices (UltraSeal XT plus and Seal-n-Glo) to gain market approval as a Class II medical device. The "Brief Description of testing performed" section lists various physical and mechanical properties that were tested (Hardness, Compressive Strength, Shrinkage, Shear Peel, Film Thickness, Viscosity/Rheometry, Sorption/Solubility), and states preferences for the results (e.g., "prefer to stay within our competitors range," "prefer higher numbers," "prefer low numbers"). However, it does not specify quantitative acceptance criteria or report the actual performance metrics for UltraSeal ID against these criteria.

Therefore, for the information requested:

A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document lists physical tests performed and general preferences, but no specific numerical acceptance ranges or the actual performance of UltraSeal ID.
Sample size used for the test set and the data provenance: Not specified in the document. The testing described is "during the R & D phase" and is comparative, but details on sample sizes or data provenance (e.g., in vivo/in vitro, country of origin, retrospective/prospective) are omitted.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes physical property testing, not a clinical study involving expert assessment or ground truth establishment in a clinical context.
Adjudication method for the test set: Not applicable. This document describes physical property testing, not a clinical study involving adjudication.
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 sealant, not an AI-powered diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental sealant, not an AI-powered device.
The type of ground truth used: For the physical/mechanical tests, the "ground truth" would be the measured properties of the predicate devices or established industry standards, but these are not explicitly stated as "ground truth." The document refers to comparing UltraSeal ID to UltraSeal XT plus and Seal-n-Glo.
The sample size for the training set: Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

In summary, the provided 510(k) pertains to a pit and fissure sealant and outlines physical/mechanical tests performed for comparison to predicate devices, but it does not detail specific acceptance criteria, study sample sizes, or clinical evaluation results in the manner requested for an AI/diagnostic device. The "Clinical Summary" mentioned states that literature was selected to support safety and efficacy claims, but the details of this literature review are not provided in this excerpt.

Summary

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SEP 1 7 2010

SPECIAL 510(K) PREMARKET SUMMARY

UltraSeal ID

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

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 Regulatory Affairs Manager 800-552-5512 x4491, 801-553-4491 801-553-4609 May 3, 2010

Name of the Device

Trade Name: Regulation Number: Device:

Device Classification: Classification Product Code: UltraSeal ID CFR 872.3765 Pit and Fissure Sealant and Conditioner ll EBC

Legally Marketed Predicate Device to Which Equivalence is Claimed Ultradent's UltraSeal XT plus (K050959) and Seal-n-Glo (K050959) are similar in that they all are Pit and Fissure Sealants. Seal-n-Glo and UltraSeal ID contain fluorescent attributes to identify the product using a compact blacklight.

Image /page/0/Picture/13 description: The image shows the logo for Ultradent Products, Inc. The logo is in black and white and features the company's name in a bold, sans-serif font. The letters "UF" are combined into a single glyph on the left side of the logo. The words "PRODUCTS, INC" are written in a smaller font below the company's name.

505 West 10200 South
South Jordan, Utah 84095, USA
www.ultradent.com
800.552.5512

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UltraSeal XT plus is manufactured by Ultradent Products Inc. 505 West 10200 South, South Jordan, UT 84095

Illuminating Pit and Fissure Sealant "Seal-n-Glo" is Delton® manufactured by Dentsply International, Susquehanna Commerce Center West, 221 West Philadelphia Street, Suite 60, York, PA 17405-0872

Brief Description of testing performed

The following tests were conducted during the R & D phase on UltraSeal ID and compared to UltraSeal XT plus (K993846) and Delton® Illuminating Pit and Fissure Sealant Seal-n-Glo (K050959). Test results are included in this 510{k).

Hardness This test shows the hardness of the bond. We a. prefer to stay within our competitors range.
b. Compressives This test shows different forces on the resin. On the Strength side, we prefer higher numbers and `mid range numbers on Modulus.
c. Shrinkage This is the percentage that the resin will shrink after curing. We prefer low numbers
d. Shear Peel This test shows higher adhesion. A high number compared to our competitors is acceptable and preferred.
e. Film Thickness We prefer lower numbers in this test to show how thin we can apply the material
f. Viscosity/Rheometry - We prefer the viscosity of the product to be low so it will flow into crevices.
Sorption/Solubility This test shows how much water the resin g. absorbs. We prefer lower reading on this test

Clinical Summary

A detailed Clinical Summary is included in this submission. It contains literature which we have selected that supports our claims for the safety and efficacy of UltraSeal ID.

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Product Description: UltraSeal ID is a 58% filled, light-cure, radiopaque, methacrylate-based, thixitropic resin sealant. UltraSeal ID technology provides visual verification for marginal retention with the use of a UV light, upon placement and at recall visits. 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.

Indications for Use: Use UltraSeal ID for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations.

	UltraSeal ID	UltraSeal XT plus	Seal-n-Glo
Indications For Use	Use UltraSeal ID forprophylactic sealingof pits and fissures.It may also be usedfor microrestorativeor "initial layer" ofcompositerestorations.	Use UltraSeal ID forprophylactic sealingof pits and fissures.It may also be usedfor microrestorativeor "initial layer" ofcompositerestorations.	Delton®Illuminating Pitand FissureSealant isindicated forpreventivesealing of pitsand fissures inthe primary andsecondarydentition incombinationwith the acid-etch technique
Delivery System	Syringe	Syringe	Syringe
Curing	Light Cured	Light Cured	Light Cured
Black light illumination	Yes	No	Yes
% Filled	58%	58%	38%

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is centered in the image and is the only element present.

Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized human figure with three lines representing the head, body, and legs. The figure is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo.

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

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

Re: K101245

SEP 1 7 2010

Trade/Device Name: UltraSeal ID Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: August 13, 2010 Received: August 18, 2010

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 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/ucm115809.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/ReportaProblem/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,

h 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

Enclosure

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K101245

SEP 1 7 2010

Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: UltraSeal ID

・) ﻪ ... ﻫ

Indications for Use: Use UltraSeal ID for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Page 1 of 1
Susan Turner

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anosthoomers

510(k) Number: K101245

(Posted November 13, 2003)

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.