CHEMICAL CURE COMPOSITE WITH ENAMEL BOND

K982191 · Medental Intl. · EBF · Sep 14, 1998 · Dental

Device Facts

• Record ID: K982191
• Device Name: CHEMICAL CURE COMPOSITE WITH ENAMEL BOND
• Applicant: Medental Intl.
• Product Code: EBF · Dental
• Decision Date: Sep 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. Enamel bonding is usually performed when composite restoration is required. The surfaces are acid-etched to allow the resin to penetrate into the microporosity, polymerized, and form resin "tags" that are mechanically bonded to the enamel.

Device Story

Chemical Cure Composite with Enamel Bond is a dental restorative material. It utilizes Bis-GMA dimethacrylate resin combined with silane-coated quartz filler particles. The material is applied to tooth surfaces that have been acid-etched to create microporosity. The resin penetrates these pores and polymerizes to form mechanical "tags" for bonding to enamel. The device is used by dental professionals in a clinical setting to restore tooth structure. It provides a chemically bonded, aesthetic alternative to amalgam for specific cavity classes.

Technological Characteristics

Material: Bis-GMA (Bisphenol A-Glycidyl Methacrylate) dimethacrylate resin with silane-coated quartz filler particles. Principle: Chemical curing/polymerization. Mechanism: Acid-etching of enamel followed by resin penetration and polymerization to form mechanical resin tags.

Indications for Use

Indicated for dental restorations, specifically Classes III to V, and Class I restorations where occlusal stress is minimal and aesthetics are required. Also used in Class II posterior restorations.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP 1 4 1998

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

K982191 Re : Chemical Cure Composite with Enamel Bond Trade Name: II Requlatory Class: EBF Product Code: Dated: June 18, 1998 Received: June 22, 1998

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 Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with General the Good Manufacturing Practice for Medical Devices: (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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Paqe 2 - Ms. Olson

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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,

S. Butner 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

510(k) Number:

Unknown

Device Name:

Chemical Cure Composite with Enamel Bond

Indications for Use:

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. Enamel bonding is usually performed when composite restoration is required. The surfaces are acid-etched to allow the resin to penetrate into the microporosity, polymerized, and form resin "tags" that are mechanically bonded to the enamel.