PREVENT SEAL

K122521 · Itena Clinical · EBC · Jun 11, 2013 · Dental

Device Facts

• Record ID: K122521
• Device Name: PREVENT SEAL
• Applicant: Itena Clinical
• Product Code: EBC · Dental
• Decision Date: Jun 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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).

Device Story

Prevent Seal is a fluoride-releasing, white, light-cured acrylate resin used by dental professionals in clinical settings. It functions as a pit and fissure sealant to prevent cavities, an initial layer for esthetic composite restorations, and a repair material for composite voids or chips. The material is applied to the tooth surface and cured using a light source (465 nm wavelength). It provides a physical barrier to protect enamel and aids in restorative procedures. The device is non-Bisphenol A based.

Clinical Evidence

Bench testing only. Performance metrics include: flexural strength (250 MPa), compressive strength (160 MPa), shear bond strength to etched enamel (35 MPa), film thickness (10 μm), and radiopacity. Light curing parameters: 20 seconds at 23°C, 465 nm wavelength, 600 mW/sqcm intensity.

Technological Characteristics

Light-cured acrylate resin containing UDMA, TEGDMA, HEMA, self-etching monomer, barium aluminoborosilicate glass, and initiators. Fluoride-releasing. Radiopaque. Form factor: dental sealant material. Curing: 465 nm light source. Non-Bisphenol A formulation.

Indications for Use

Indicated for dental professionals to fill/seal pit and fissure depressions in teeth to prevent cavities, serve as an initial layer for composite restorations, and repair composite restorations (voids, porosities, chips), primarily in young children.

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

• HelioSeal F (K932078)
• IPS Empress Direct Flow (K103528)

Submission Summary (Full Text)

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# 510(k) Summary

### K122521

1. 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: [phone] [phone] Fax: Email: [e-mail]

3. Date Summary Prepared: July 30th, 2012

- 4. Devices Names: Prevent Seal
. 5. Device Classification: II

- 6. 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:

| Technological<br>Characteristics | Subject Device | HelioSeal F<br>K932078 | IPS Empress Direct Flow<br>K103528 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type | light-cured acrylate<br>resin | light-cured<br>acrylate<br>resin | light-cured acrylate resin |
| Intended Use | • to fill and seal<br>pit and fissure<br>depressions<br>(faults in the<br>enamel) of teeth<br>to prevent<br>cavities;<br>• covering layer or<br>"initial layer" in<br>the fabrication of<br>esthetically<br>demanding<br>composite<br>restorations;<br>• for repairs of<br>composite<br>restorations (in<br>particular filling<br>of voids,<br>leveling out of<br>porosities and<br>minor chips). | To fill and<br>seal the pits<br>and fissures<br>of teeth. | • As an intermediate or covering layer<br>in the fabrication of esthetically<br>demanding composite restorations<br>• Repair of composite restorations (in<br>particular filling of voids, levelling<br>out of porosities and minor chips)<br>• As a thin (< 0.5mm) initial layer<br>under Class I and 11 restorations;<br>• Small restorations of all types;<br>• Extended fissure sealing;<br>• Splinting of mobile teeth;<br>• Blocking out of undercuts;<br>• Repair of composite and ceramic<br>veneers |
| Composition | UDMA<br>TEGDMA<br>HEMA<br>Self-etching<br>monomer<br>Barium<br>aluminoborosilicate<br>glass<br>initiators | UDMA<br>TEGDMA<br>Bis-GMA,<br>titanium<br>dioxide,<br>initiators<br>and<br>stabilizers | UDMA<br>Bis-GMA<br>Tricyclodocandimethanoldimethacrylat<br>Decamethylene dimethacrylate<br>Barium glass, ytterbium trifluoride,<br>dispersed silicon dioxide, mixed oxide<br>and copolymer |
| Fluoride<br>Release | 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<br>(MPa) | 250 |
|--------------------------------------------------|-------|
| Compressive<br>Strength (MPa) | 160 |
| Shear Bond<br>Strength to Etched<br>Enamel (MPa) | 35 |
| Light Curing Time<br>@ 23°C (sec) | 20 |
| Sensitivity to<br>Ambient Light @<br>22°C (sec) | 75 |
| Film Thickness<br>(μm) | 10 |
| Radiopacity | Yes |
| Wavelength (nm) | 465 |
| Intensity of the<br>light source<br>(mW/sqcm) | 600 |
| Shade | White |

13. 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 [phone] or [phone] 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 [phone] or [phone] 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