MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1

K982779 · Medental Intl. · EMA · Sep 30, 1998 · Dental

Device Facts

• Record ID: K982779
• Device Name: MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1
• Applicant: Medental Intl.
• Product Code: EMA · Dental
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Glass Ionomer cement is used in a luting application and referred to as a cement for the attachment of indirect restorations and appliances to the teeth. The glass ionomer cements also bond adhesively to tooth structure and they inhibit infiltration of oral fluids at the cement-tooth interface.

Device Story

Glass ionomer cement used by dental professionals for luting indirect restorations and appliances. Material bonds adhesively to tooth structure; inhibits infiltration of oral fluids at cement-tooth interface. Applied in clinical dental settings to secure crowns, bridges, or other appliances. Benefits include stable attachment and reduced microleakage at the restoration margin.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Glass ionomer cement; luting agent; adhesive bonding properties; inhibits fluid infiltration.

Indications for Use

Indicated for luting applications, specifically the attachment of indirect dental restorations and appliances to tooth structure.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

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

Re : K982779 Trade Name: Medental Glass Ionomer Cement Type I and Mirage Glass Ionomer Regulatory Class: II Product Code: EMA Dated: August 5, 1998 August 7, 1998 Received:

Dear Ms. Olson:

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 may 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 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.

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 Requlations, 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 regulation 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. Olson

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 regulation (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,

Patricia Cueniffa

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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

510(k) Number:

Not Yet Assigned

Device Name:

Glass Ionomer Cement Type 1

Indications for Use:

Glass Ionomer cement is used in a luting application and referred to as a cement for the attachment of indirect restorations and appliances to the teeth. The glass ionomer cements also bond adhesively to tooth structure and they inhibit infiltration of oral fluids at the cement-tooth interface.

Susa Ramer

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices after 510(k) Number