MULTI-CURE COMPOSITE CEMENT

K990314 · Medental Intl. · EBF · Apr 2, 1999 · Dental

Device Facts

• Record ID: K990314
• Device Name: MULTI-CURE COMPOSITE CEMENT
• Applicant: Medental Intl.
• Product Code: EBF · Dental
• Decision Date: Apr 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Multi-Cure composite cement is used as a luting cement for veneers, crowns, and bridges for anterior and posterior teeth. Composite restorative materials were developed by Dr. Raphael Bowen working for American Dental Research. The main innovation was Bisphenol A-Glycidyl Methacrylate (Bis-GMA), a dimethacrylate resin with silane coated filler (quartz) particles. These coated particles could bond chemically to the Bis-GMA resin. This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also.

Device Story

Multi-Cure Composite Cement is a dental luting material consisting of base and catalyst pastes. Upon mixing, the pastes undergo an exothermic reaction. The reaction is accelerated by visible light curing via camphorquinone and dimethylaminoethyl methacrylate. The material utilizes Bis-GMA resin with silane-coated quartz filler particles to facilitate chemical bonding. Used by dental professionals in clinical settings for cementation of restorations (veneers, crowns, bridges) and specific cavity classifications (I, III-V). The device provides a restorative or luting function to improve tooth appearance and structural integrity in dental procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Composition: Bis-GMA (Bisphenol A-Glycidyl Methacrylate) resin with silane-coated quartz filler particles. Principle: Dual-cure (chemical exothermic reaction accelerated by visible light). Form: Two-paste system (base and catalyst).

Indications for Use

Indicated for use as a luting cement for veneers, crowns, and bridges on anterior and posterior teeth. Recommended for Class III to V restorations and Class I restorations where occlusal stress is not a concern and aesthetics are required.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Public Health Service

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APR 2 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K990314 Multi-Cure Composite Cement Trade Name: Requlatory Class: II Product Code: EBF March 17, 1999 Dated: Received: March 18, 1999

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 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) requlation (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 leqally 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 qeneral 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,

Valerian Crescent for

Timothy A. Ulatowski 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

Unknown 510(k) Number:

Device Name:

Multi-Cure Composite Cement

Indications for Use:

Multi-Cure composite cement is used as a luting cement for veneers, crowns, and bridges for anterior and posterior teeth. Composite restorative materials were developed by Dr. Raphael Bowen working for American Dental Research. The main innovation was Bisphenol A-Glycidyl Methacrylate (Bis-GMA), a dimethacrylate resin with silane coated filler (quartz) particles. These coated particles could bond chemically to the Bis-GMA resin. This is recommended for use for Classes III to V and for Class I when oclusal stress is not a problem and appearance is crucial. Although less durable than amalgam composite designed for Class II posterior applications, it is now used in about 20% of these restorations also.

The base paste and catalyst paste when mixed together form an exothermic reaction. When a standard dental curing light in the visible wave-length range is used it will cause the camphorquinone and the liquid "A" dimethylaminoethyl methacrylate to accelerate this reaction.

Angela Blackwell for msR

and General Hossala K990314 510(k) Number -

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