CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)

K973919 · Medental Intl. · LBH · Dec 16, 1997 · Dental

Device Facts

• Record ID: K973919
• Device Name: CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
• Applicant: Medental Intl.
• Product Code: LBH · Dental
• Decision Date: Dec 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cavity varnish is used for sealing cavities before restorations. It provides a barrier against the passage of irritants from cements or other restorative materials and reduces the penetration of oral fluids at the restoration-tooth interface into the underlying dentin. It also minimizes postoperative sensitivity when applied to dentinal surfaces under newly placed restorations.

Device Story

Dentinal Tubuli Seal is a cavity varnish applied by dental professionals to prepared tooth cavities. It functions as a protective barrier between the tooth structure and restorative materials (e.g., cements). By sealing dentinal tubules, it prevents the ingress of oral fluids and chemical irritants from restorative materials into the dentin. This application reduces postoperative sensitivity for patients undergoing dental restorations. The device is used in a clinical dental setting.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cavity varnish formulation designed for application to dentinal surfaces. Acts as a physical barrier/sealant. No electronic, software, or complex mechanical components.

Indications for Use

Indicated for sealing dental cavities prior to restoration placement to provide a barrier against irritants from restorative materials, reduce oral fluid penetration at the restoration-tooth interface, and minimize postoperative sensitivity.

Regulatory Classification

Identification

Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Submission Summary (Full Text)

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, depicted with stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debra Gillaspy Official Correspondent Medental International 1246 Clear Creek Road Evergreen, Colorado 80439

DEC 1 6 1997

K973919 Re : Cavity Varnish (Intermediary Varnish and Trade Name: Dentinal Tubuli Seal) Requlatory Class: II Product Code: LBH October 7, 1997 Dated: October 15, 1997 Received:

Dear Ms. Gillaspy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Ms. Gillaspy

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timot Ulatowsk Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## MEDENTAL INTERNATIONAL 1246 Clear Creek Road Evergreen, CO 80439 Establishment # 1723973

510(k) Number:

Not Yet Assigned K973919

Device Name:

Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)

Indications for Usc:

Cavity varnish is used for sealing cavities before restorations. It provides a barrier against the passage of irritants from cements or other restorative materials and reduces the penetration of oral fluids at the restoration-tooth interface into the underlying dentin. It also minimizes postoperative sensitivity when applied to dentinal surfaces under newly placed restorations.

Susan Runnes
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices 510(k) Number . KA-

Prescription Use Yu

s

Over the Counter Use No