(295 days)
Prevent Seal is used by dental profesionnals primarily in young children :
- . To fill and seal pit and fissure depressions (faults in the enamel) of teeth to prevent cavities :
- . Covering layer or " initial layer " in the fabrication of esthetically demanding composite restorations ; and
- . For repairs of composite restorations (in particular filling of voids, leveling out of porosities and minor chips).
Prevent Seal is a fluoride releasing, white, light-cured acrylate resin. Not manufactured with Bisphenol A.
Here's the analysis of the provided text regarding the acceptance criteria and study for the Prevent Seal device, formatted as requested:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated, Inferred from Performance Data) | Reported Device Performance |
|---|---|
| Flexural Strength (MPa) | 250 |
| Compressive Strength (MPa) | 160 |
| Shear Bond Strength to Etched Enamel (MPa) | 35 |
| Light Curing Time @ 23°C (sec) | 20 |
| Sensitivity to Ambient Light @ 22°C (sec) | 75 |
| Film Thickness (µm) | 10 |
| Radiopacity | Yes |
| Wavelength (nm) | 465 |
| Intensity of the light source (mW/sqcm) | 600 |
| Shade | White |
Note: The document lists "Summary of Performance Testing" which includes these metrics and their corresponding values. It does not explicitly state "acceptance criteria" with specific thresholds that the device had to meet. The provided values are the reported performance of the device based on the laboratory testing. This submission appears to rely on demonstrating performance comparable to predicate devices rather than meeting pre-defined specific numerical acceptance criteria.
Regarding the study that proves the device meets the acceptance criteria, based on the provided text, the following information is available:
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not specified in the provided text.
- Data provenance: "laboratory results". No specific country of origin is mentioned, but the submitter is based in France and the contact person in Canada. The testing explicitly states "laboratory results", implying prospective testing for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not specified. The performance testing appears to be objective, quantitative laboratory measurements of physical and mechanical properties, not subjective expert evaluation requiring ground truth establishment through consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. The reported performance metrics are results of laboratory tests (e.g., strength, curing time) and do not involve human adjudication for a test set.
5. 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:
- No, an MRMC comparative effectiveness study was not done. The device is a pit and fissure sealant, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a medical device (a sealant material), not an algorithm or AI system. The performance documented is of the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective laboratory measurements: The "ground truth" for the reported performance metrics (Flexural Strength, Compressive Strength, etc.) is the direct measurement obtained from standardized laboratory tests. There is no human-interpreted "ground truth" in the traditional sense for these material properties.
8. The sample size for the training set:
- Not applicable. This device is not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI model, so there is no training set or associated ground truth.
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510(k) Summary
K122521
- Name/Address of Submitter: Itena Clinical JUN 1 1 2013 83 avenue Foch 75116 Paris FRANCE 2.
Contact Person: Louis-Paul Marin Co-President, BCF Certification inc. Phone: (514) 397-5546 (514) 397-8515 Fax: Email: Ipmarin@bcf.ca
- Date Summary Prepared: July 30th, 2012
-
- Devices Names: Prevent Seal
. 5. Device Classification: II
- Devices Names: Prevent Seal
-
- Common name: Pit and Fissure Sealant
-
Classification Product Code: EBC; 21 CFR 872.3765 7.
8. Predicate Devices:
HelioSeal F K932078 IPS Empress Direct Flow K103528
9. Device Description:
Prevent Seal is a fluoride releasing, white, light-cured acrylate resin. Not manufactured with Bisphenol A.
10. Indication for Use:
Prevent Seal is used by dental professionals primarily in young children:
- to fill and seal pit and fissure depressions (faults in the enamel) of teeth to prevent . cavities:
- . covering layer or "initial layer" in the fabrication of esthetically demanding composite restorations; and
- . for repairs of composite restorations (in particular filling of voids, leveling out of porosities and minor chips).
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11. Comparison with Predicate Products:
Prevent Seal is substantially equivalent in design, composition, intended use and performance to the predicate products listed above, notably as regards the following:
| TechnologicalCharacteristics | Subject Device | HelioSeal FK932078 | IPS Empress Direct FlowK103528 |
|---|---|---|---|
| Type | light-cured acrylateresin | light-curedacrylateresin | light-cured acrylate resin |
| Intended Use | • to fill and sealpit and fissuredepressions(faults in theenamel) of teethto preventcavities;• covering layer or"initial layer" inthe fabrication ofestheticallydemandingcompositerestorations;• for repairs ofcompositerestorations (inparticular fillingof voids,leveling out ofporosities andminor chips). | To fill andseal the pitsand fissuresof teeth. | • As an intermediate or covering layerin the fabrication of estheticallydemanding composite restorations• Repair of composite restorations (inparticular filling of voids, levellingout of porosities and minor chips)• As a thin (< 0.5mm) initial layerunder Class I and 11 restorations;• Small restorations of all types;• Extended fissure sealing;• Splinting of mobile teeth;• Blocking out of undercuts;• Repair of composite and ceramicveneers |
| Composition | UDMATEGDMAHEMASelf-etchingmonomerBariumaluminoborosilicateglassinitiators | UDMATEGDMABis-GMA,titaniumdioxide,initiatorsandstabilizers | UDMABis-GMATricyclodocandimethanoldimethacrylatDecamethylene dimethacrylateBarium glass, ytterbium trifluoride,dispersed silicon dioxide, mixed oxideand copolymer |
| FluorideRelease | Yes | Yes | No |
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· 12. Summary of Performance Testing:
The following laboratory results demonstrate that Prevent Seal performs as intended:
| Flexural Strength(MPa) | 250 |
|---|---|
| CompressiveStrength (MPa) | 160 |
| Shear BondStrength to EtchedEnamel (MPa) | 35 |
| Light Curing Time@ 23°C (sec) | 20 |
| Sensitivity toAmbient Light @22°C (sec) | 75 |
| Film Thickness(μm) | 10 |
| Radiopacity | Yes |
| Wavelength (nm) | 465 |
| Intensity of thelight source(mW/sqcm) | 600 |
| Shade | White |
- Conclusion Drawn: Based on the above comparisons, the laboratory testing results, a search of the relevant literature and the organizational experience with Prevent Seal, Itena Clinical concludes that the subject device is substantially equivalent to the predicate devices (HelioSeal F K932078, and IPS Empress Direct Flow K103528) and that the subject device is safe and effective for its intended uses.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a graphic representation of a human figure embracing or protecting another, often interpreted as representing the department's mission of protecting and promoting the health and well-being of Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2013
Itena Clinical C/O Mr. Louis-Paul Marin Co-President BCF Certification, Incorporated 500 Boul Cartier West Laval H7V 5B7 CANADA
Re: K122521
Trade/Device Name: Prevent Seal Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: May 24, 2013 Received: May 28, 2013
Dear Mr. Marin:
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 - Mr. Marin
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Mary S.
Susan Runner -S-
Kwame Ulmer M.S. Acting Division 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): K122521
Device Name : Prevent Seal
Indications For Use :
Prevent Seal is used by dental profesionnals primarily in young children :
- . To fill and seal pit and fissure depressions (faults in the enamel) of teeth to prevent cavities :
- . Covering layer or " initial layer " in the fabrication of esthetically demanding composite restorations ; and
- . For repairs of composite restorations (in particular filling of voids, leveling out of porosities and minor chips).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE) 2013.06.07 09:29:08 504.00
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K22521
§ 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.