(257 days)
PacSeal™ Pit & Fissure Sealant is intended for use as:
- Seal the pits and fissures in teeth
PacSeal™ Pit & Fissure Sealant is a fluoride releasing, light-cured acrylate resin designed to fill and seal the pits and fissures of teeth.
Here's a breakdown of the acceptance criteria and study information for the PacSeal™ Pit & Fissure Sealant as derived from the provided document:
This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with specific acceptance criteria in the manner of a novel device. Therefore, the "acceptance criteria" are implied by the comparison to the predicate device's performance characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds. Instead, it compares the subject device's performance to that of predicate devices, implicitly suggesting that performance comparable to or better than the predicate is acceptable.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (PacSeal™ Pit & Fissure Sealant) |
|---|---|---|
| Depth of Cure (ISO 6874-2005) | Comparable to or better than 1.86 mm (3M™ Clinpro™ Sealant) | Complies (with ISO 6874-2005) |
| Compressive Strength | Comparable to or better than 210 MPa (3M™ Clinpro™ Sealant) | 181 MPa |
| Diametral Tensile Strength | Comparable to or better than 37 MPa (3M™ Clinpro™ Sealant) | Subject device is equivalent to the predicate device |
| Film Thickness | Comparable to or better than 10 µm (3M™ Clinpro™ Sealant) | Subject device is equivalent to the predicate device |
| Flexural Strength (ISO 4049-2009) | Comparable to or better than 110 MPa (3M™ Clinpro™ Sealant) | Complies (with ISO 4049-2009) |
| Light Curing Time (ISO 6874-2005) | 30 sec (matches 3M™ Clinpro™ Sealant) | 30 sec |
| Shear Bond Strength to Etched Enamel | Comparable to or better than 8.12 MPa (3M™ Clinpro™ Sealant) | Subject device is equivalent to the predicate device |
Note: For "Compressive Strength," the subject device (181 MPa) is lower than the predicate (210 MPa). The document still concludes substantial equivalence, suggesting that this difference was deemed acceptable in the context of overall performance and "equivalent to the predicate" claim for other properties.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for the performance tests (e.g., number of specimens for depth of cure, strength tests).
The data provenance is not explicitly stated beyond being presented in a 510(k) summary by Pac-Dent International, Inc. These types of tests are typically in-vitro laboratory tests, not clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to the data provided. The "ground truth" for these physical property tests is based on standardized laboratory measurements (e.g., ISO standards) and not on expert consensus from human readers or clinicians.
4. Adjudication Method for the Test Set
This is not applicable as the tests are for physical properties measured in a lab, not for diagnostic or interpretive tasks requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This document describes the physical and chemical characteristics of a dental sealant, not an AI or imaging device that would typically undergo MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not relevant to the device described. The device is a physical dental sealant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance characteristics (e.g., depth of cure, strength, film thickness) is based on standardized laboratory test methods (e.g., ISO 6874-2005, ISO 4049-2009).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2015
Pac-Dent International, Inc. Ms. Wenying Zhu Materials Engineer 21038 Commerce Point Dr. Walnut, California 91789
Re: K141717
Trade/Device Name: Pacseal Pit & Fissure Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and fissure sealant and conditioner Regulatory Class: Class II Product Code: EBC Dated: January 29, 2015 Received: February 6, 2015
Dear Ms. Zhu:
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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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 (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". The signature is complex and illegible. There is also a small "-s" below the name.
for Erin I. Keith, M.S. 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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Image /page/2/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with the "R" in a circle next to it, indicating a registered trademark. Below "PacDent" is the text "International, Inc." in a smaller font, and below that is the phrase "passion for excellence..."
Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
Section III
Indications for Use Statement
510(k) Number (if known): K141717
Device Name: _ PacSeal™ Pit & Fissure Sealant
Indications for Use:
PacSeal™ Pit & Fissure Sealant is intended for use as:
- Seal the pits and fissures in teeth
Prescription Use
OR
Over-The-Counter Use
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Image /page/3/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with a white swoosh underneath. Below that, the words "International, Inc." are in a smaller, white font, and below that, the words "passion for excellence..." are in a smaller, orange font.
Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
Section IV
510(k) Summary
Submitter:
Pac-Dent International, Inc. 21038 Commerce Point Dr. Walnut, CA91789 Contact Person: Wenying Zhu Materials Engineer 909-839-0888 ext.111 Date Summary Prepared: June 2014
Device Name
Trade Name: PacSeal™ Pit & Fissure Sealant Common Name: Pit and Fissure Sealant Device Classification: Class II Classification Product Code: EBC Classification Name: Pit and Fissure Sealant and Conditioner per 21 CFR 872.3765
Predicate Device
3MTM Clinpro™ Sealant (K992326) Prevent Seal (K122521)
Description of Device
PacSeal™ Pit & Fissure Sealant is a fluoride releasing, light-cured acrylate resin designed to fill and seal the pits and fissures of teeth.
Indications for Use
Seal the pits and fissures in teeth
Summary of Biocompatibility Tests
The biocompatibility of PacSeal™ Pit & Fissure Sealant was found to be substantially equivalent to the predicate based on a risk assessment and the identification of legally marketed predicate devices for all ingredients in the chemical composition.
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Image /page/4/Picture/0 description: The image shows the logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, black font, with a curved white line underneath. Below this, the words "International, Inc." are in a smaller, white font, and below that, the words "passion for excellence..." are in a smaller, orange font.
Pac-Dent International, Inc.
21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
Comparison of Technological Characteristics and Performance
| DescriptiveInformation | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|
| PacSeal™ Pit & Fissure Sealant | 3M™ Clinpro™ Sealant (K992326) | Prevent Seal (K122521) | |
| Indication forUse | Seal the pits and fissures in teeth | Pit and fissure sealant | To fill and seal pit andfissure depressions ofteeth to prevent cavitiesCovering layer or "initiallayer" in the fabricationof estheticallydemanding compositerestorationsFor repairs of compositerestorations |
| Composition ofMaterials | TEGDMABISGMAUDMAGlass particle filler (0.18µm -1.0µm)Photoinitiator | TEGDMABISGMAGlass particle filler (0.1µm -5.0µm)Photoinitiator | UDMATEGDMAHEMAGlass particle fillerPhotoinitiator |
| PhysicalProperties andFDA-RecognizedStandards | Depth of Cure- ISO 6874-2005: compliesCompressive Strength: 181 MPaDiametral Tensile Strength: subjectdevice is equivalent to the predicatedeviceFilm Thickness: subject device isequivalent to the predicate deviceFlexural Strength- ISO 4049-2009:compliesLight Curing Time- ISO 6874-2005: 30 secShear Bond Strength to EtchedEnamel: subject device is equivalentto the predicate device | Depth of Cure- ISO 6874-2005: 1.86 mmCompressive Strength: 210 MPaDiametral Tensile Strength: 37MPaFilm Thickness: 10µmFlexural Strength- ISO 4049-2009:110 MPaLight Curing Time- ISO 6874-2005: 30 secShear Bond Strength to EtchedEnamel: 8.12 MPa | N/A |
| Delivery system | 1.2 mL pre-filled syringe | 1.2 mL pre-filled syringe6 mL bottle | 1.2 mL pre-filled syringe |
Based on the above comparisons and performance test results, Pac-Dent concludes that the subject device is substantially equivalent in intended use, composition, delivery system and performance to the predicate device. Physical properties evaluated include depth of cure,
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Image /page/5/Picture/0 description: The image is a logo for PacDent International, Inc. The logo is set against an orange background. The words "PacDent" are in a bold, sans-serif font, with a curved line underneath. Below that, the words "International, Inc." are in a smaller font. The tagline "passion for excellence..." is at the bottom of the logo.
Pac-Dent International, Inc. 21038 Commerce Pointe Dr. Walnut = California = 91789
t: 909.839.0888 f: 909.839.0881 www.pac-dent.com
compressive strength, diametral tensile strength, film thickness, flexural strength, light curing time and shear bond strength to etched enamel.
Substantial Equivalence
In summary, this submission demonstrates that PacSeal™ Pit & Fissure Sealant is substantially equivalent to the identified predicate products for its intended use.
§ 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.