(246 days)
Not Found
No
The device description and performance studies focus on the material properties and physical performance of the sealant, with no mention of AI or ML.
No.
The device is a pit and fissure sealant, which is a dental material used to prevent cavities, not to treat an existing disease or condition. While preventative, it is not considered a therapeutic device in a medical sense.
No
The device is a pit and fissure sealant, which means it is used to seal teeth, not to diagnose a condition or disease. Its performance studies focus on physical properties and biocompatibility, not diagnostic accuracy.
No
The device description clearly states it is a "light-cured, fluoride containing, resin-based pit & fissure sealant," which is a physical material applied to teeth, not software. The performance studies also focus on material properties like shear bond strength, light curability, and biocompatibility, further indicating it is a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or determine the state of health.
- This device is a pit and fissure sealant. It is applied directly to the teeth to seal pits and fissures. It does not examine any specimen from the body.
The description clearly indicates its function is a physical sealant applied to the tooth structure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
Pit and fissure sealant
Product codes (comma separated list FDA assigned to the subject device)
EBC
Device Description
HAPI Seal is a light-cured, fluoride containing, resin-based pit & fissure sealant designed for sealing the enamel pits and fissures of teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
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)
HAPI Seal meets ISO 6874:2015 "Dentistry - Polymer-based pit and fissure sealants." Shear bond strength was tested based upon ISO 29022:2013 Dentistry - Adhesion - Notched-edge shear bond strength test. Additionally, Light Curability, Ambient Light Sensitivity, Depth of Cure, Flexural Strength, Flexural Modulus, Cumulative Fluoride Release, Compressive Strength, Surface Hardness, and Shrinkage were tested and demonstrate HAPI Seal is substantially equivalent to the predicate device.
HAPI Seal is equivalent to the predicate for: Shear Bond Strength (Modified ISO 29022), Light Curability (Cure time) Ambient Light Sensitivity, Flexural Modulus (ANSI/ADA Spec No. 27), Cumulative Fluoride Release, Compressive Strength (ANSI/ADA Spec No. 27), Surface Hardness (Barcol-Colman 934-1), Shrinkage (Volumetric).
HAPI Seal meets the requirements of ISO 6874:2015 for Depth of Cure.
HAPI Seal meets the requirements of ISO 4049:2009 for Flexural Strength.
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.
Not Found
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2017
Bisco, Inc. Ryan Hobson Regulatory Affairs Product Registration Coordinator 1100 West Irving Park Rd. Schaumburg, Illinois 60193
Re: K162598
Trade/Device Name: HAPI Seal Regulation Number: 21 CFR 872.3765 Regulation Name: Pit And Fissure Sealant And Conditioner Regulatory Class: Class II Product Code: EBC Dated: May 23, 2017 Received: May 23, 2017
Dear Ryan Hobson:
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.
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 of medical devicerelated 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.
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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.
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Acting 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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Indications for Use
510(k) Number (if known) K162598
Device Name HAPI Seal
Indications for Use (Describe) Pit and fissure sealant
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K162598
510(k) SUMMARY
Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193
Contact Person:
Applicant:
Ryan Hobson Tel: 847-534-6143 Fax: 847-534-6143
Date Prepared:
19 May 2017
Trade Name: Common Name: Product Code: Classification/Name: HAPI Seal Pit & Fissure Sealant ЕВС Pit and fissure sealant and conditioner Class II per 21 CFR 872.3765
Predicate Devices:
HAPI Seal is substantially equivalent to:
Clinpro by 3M Company, K992326
Indications for Use:
Pit and fissure sealant
Description of Applicant Device:
HAPI Seal is a light-cured, fluoride containing, resin-based pit & fissure sealant designed for sealing the enamel pits and fissures of teeth.
Comparison of Technological Characteristics:
Indications for use
HAPI Seal indications for use are identical to that of the predicate device and summarized in the table below:
| Clinpro
| K992326 | HAPI Seal |
|---|---|
| Pit and fissure sealant | Pit and fissure sealant |
All components of HAPI Seal are based upon industry standard chemistry. The chemical composition of HAPI Seal is similar to Clinpro, methacrylate based chemistry, and is summarized in the table below:
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
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510(k) SUMMARY (continued)
| Chemical Composition | Clinpro | HAPI Seal |
|---|---|---|
| K992326 | ||
| Filler | Silica | Silica |
| Resin composition | Methacrylate Resin | Methacrylate Resin |
| Polymerization Method | light cured | light cured |
| lons Released | Fluoride | Fluoride |
| Physical Mechanical Property | Clinpro
K992326 | HAPI Seal |
|------------------------------|----------------------|----------------------|
| Depth of Cure | Meets ISO 6874:2015 | Meets ISO 6874:2015 |
| lons Released | Fluoride releasing | Fluoride releasing |
| Polymerization time | 20 second light cure | 20 second light cure |
| Bonding | Bonds to enamel | Bonds to enamel |
Performance Data:
HAPI Seal meets ISO 6874:2015 "Dentistry - Polymer-based pit and fissure sealants." Shear bond strength was tested based upon ISO 29022:2013 Dentistry - Adhesion - Notched-edge shear bond strength test. - Additionally, Light Curability, Ambient Light Sensitivity, Depth of Cure, Flexural Strength, Flexural Modulus, Cumulative Fluoride Release, Compressive Strength, Surface Hardness, and Shrinkage were tested and demonstrate HAPI Seal is substantially equivalent to the predicate device. A comparison of the physical/mechanical properties of HAPI Seal to the predicate device is provided in the table below.
| Physical / Mechanical Property | HAPI Seal |
|---|---|
| Shear Bond Strength | |
| (Modified ISO 29022) | HAPI Seal is equivalent to the predicate. |
| Light Curability (Cure time) | |
| Ambient Light Sensitivity | HAPI Seal is equivalent to the predicate. |
| Depth of Cure | |
| (ISO 6874:2015) | HAPI Seal meets the requirements of ISO 6874:2015. |
| Flexural Strength | |
| (ISO 4049:2009) | HAPI Seal meets the requirements of ISO 4049:2009 for |
| Flexural Strength. | |
| Flexural Modulus | |
| (ANSI/ADA Spec No. 27) | HAPI Seal is equivalent to the predicate |
| Cumulative Fluoride Release | HAPI Seal is equivalent to the predicate. |
| Compressive Strength | |
| (ANSI/ADA Spec No. 27) | HAPI Seal is equivalent to the predicate. |
| Surface Hardness | |
| (Barcol-Colman 934-1) | HAPI Seal is equivalent to the predicate. |
| Shrinkage (Volumetric) | HAPI Seal is equivalent to the predicate. |
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510(k) SUMMARY (continued)
Biocompatibility:
An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the biocompatibility of HAPI Seal. Cytotoxicity and Oral Toxicity testing was completed. It is concluded from the biocompatibility evaluation and the results of Oral Toxicity Study (10 mice, 14 days) that HAPI Seal was not toxic in this test.
Conclusion:
It is concluded from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that HAPI is substantially equivalent to the predicate devices.
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com