Who is the manufacturer of ULTRASEAL ID?

Ultradent Products, Inc. filed the 510(k) submission for ULTRASEAL ID (K101245).

What is the FDA product code for ULTRASEAL ID?

EBC. It is classified under 21 CFR 872.3765 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ULTRASEAL ID?

510(k) clearance (submission type: Special).

What are the predicate devices for ULTRASEAL ID?

UltraSeal XT plus (K050959); Seal-n-Glo (K050959).

Who can help prepare an FDA 510(k) submission like ULTRASEAL ID?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ULTRASEAL ID

K101245 · Ultradent Products, Inc. · EBC · Sep 17, 2010 · Dental

Device Facts

Record ID	K101245
Device Name	ULTRASEAL ID
Applicant	Ultradent Products, Inc.
Product Code	EBC · Dental
Decision Date	Sep 17, 2010
Decision	SESE
Submission Type	Special
Regulation	21 CFR 872.3765
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

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

Device Story

UltraSeal ID is a 58% filled, light-cure, radiopaque, methacrylate-based, thixotropic resin sealant. It is applied by dental professionals to tooth surfaces to seal pits and fissures, preventing cavities. The device features fluorescent attributes, allowing clinicians to verify marginal retention and placement using a compact UV (black) light. It is intended for use in young children and other patients requiring dental restoration. The sealant flows into crevices due to its thixotropic properties and is cured via light application. The primary benefit is the ability to visually confirm the presence and integrity of the sealant during initial placement and subsequent recall visits.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing comparing physical properties (hardness, compressive strength, shrinkage, shear peel, film thickness, viscosity, and sorption/solubility) against predicate devices UltraSeal XT plus and Seal-n-Glo. Literature supporting safety and efficacy is cited.

Technological Characteristics

58% filled, light-cure, radiopaque, methacrylate-based, thixotropic resin. Delivered via syringe. Features fluorescent additives for UV light-based visualization. No electronic components or software.

Indications for Use

Indicated for prophylactic sealing of pits and fissures and as an initial layer for composite restorations in patients requiring dental cavity prevention.

Regulatory Classification

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.

Predicate Devices

UltraSeal XT plus (K050959)
Seal-n-Glo (K050959)

Related Devices

K112517 — ULTRASEAL XT HYDRO · Ultradent Products, Inc. · Sep 23, 2011
K963921 — PULPDENT SEAL-RITE UDMA · Pulpdent Corp. · Nov 12, 1996
K050959 — DELTON ILLUMINATING PIT AND FISSURE SEALING · Dentsply International · May 11, 2005
K012761 — PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT · Prime Dental Manufacturing, Inc. · Nov 1, 2001
K243254 — Parkell Pit and Fissure Sealant · Parkell, Inc. · Aug 8, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations. | Use UltraSeal ID for prophylactic sealing of pits and fissures. It may also be used for microrestorative or "initial layer" of composite restorations. | Delton® Illuminating Pit and Fissure Sealant is indicated for preventive sealing of pits and fissures in the primary and secondary dentition in combination with 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% | . {3}------------------------------------------------ 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. {4}------------------------------------------------ ### 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 {5}------------------------------------------------ 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)