(136 days)
No
The device description focuses on the material properties and visual verification method using UV light, with no mention of AI or ML.
No
The device is a pit and fissure sealant intended to prevent cavities, which is a prophylactic measure rather than a treatment for an existing disease or condition.
No
Explanation: The device is a pit and fissure sealant used for prophylactic sealing and microrestorative purposes. Its primary function is to prevent cavities, not to diagnose medical conditions. While it allows for "visual verification for marginal retention with the use of a UV light," this feature serves as a check of the sealant's application, not a diagnosis of a patient's health or disease.
No
The device description clearly states it is a "58% filled, light-cure, radiopaque, methacrylate-based, thixitropic resin sealant," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "prophylactic sealing of pits and fissures" and "microrestorative or 'initial layer' of composite restorations." This is a direct application to the patient's teeth for preventative and restorative purposes.
- Device Description: The description details a "resin sealant" applied to teeth to prevent cavities.
- Anatomical Site: The device is applied to "Pits and fissures in the biting surfaces of teeth."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device itself is the treatment/preventative measure.
IVD devices are used outside the body to analyze samples from the body. This device is applied to the body for a therapeutic/preventative effect.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EBC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pits and fissures in the biting surfaces of teeth
Indicated Patient Age Range
primarily in young children
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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)