Premier Sealant

K161580 · Premier Dental Company Products · EBC · Oct 18, 2016 · Dental

Device Facts

• Record ID: K161580
• Device Name: Premier Sealant
• Applicant: Premier Dental Company Products
• Product Code: EBC · Dental
• Decision Date: Oct 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or "initial layer" of composite restorations.

Device Story

Premier Sealant is a dental material used by clinicians for the prophylactic sealing of pits and fissures to prevent dental caries. It also functions as a micro-restorative or initial layer for composite restorations. The device is applied in a clinical setting by dental professionals. It serves as a physical barrier to protect tooth surfaces or as a base layer in restorative procedures, aiding in the preservation of tooth structure and the longevity of composite fillings.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pit and fissure sealant and conditioner; Class II device (21 CFR 872.3765); product code EBC.

Indications for Use

Indicated for prophylactic sealing of pits and fissures and as a micro-restorative or initial layer for composite restorations in patients requiring dental caries prevention or treatment.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 18, 2016

Premier Dental Company Products Vincent D'Alessandro Regulatory Manager Premier Dental Products Company 1710 Romano Drive Plymouth Meeting, Pennsylvania 19462

Re: K161580 Trade/Device Name: Premier Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit And Fissure Sealant And Conditioner Regulatory Class: Class II Product Code: EBC Dated: July 21, 2016 Received: July 21, 2016

Dear Vincent D'Alessandro:

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

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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 [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" (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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Michael J. Ryan -S

for Tina Kiang, Ph.D. 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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1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A. 888-773-6872 / 610-239-6000 www.premusa.com

## Indications for Use

510(k) Number (if known): K161580

Device Name: Premier Sealant

Indications for Use: Premier Sealant, a prescription only medical device used for prophylactic sealing of pits and fissures. It may also be used for micro-restorative or "initial layer" of composite restorations.

Prescription Use X X

(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)