QUADRANT POSTERIOR DENSE

K984044 · Cavex Holland BV · EBF · Dec 16, 1998 · Dental

Device Facts

• Record ID: K984044
• Device Name: QUADRANT POSTERIOR DENSE
• Applicant: Cavex Holland BV
• Product Code: EBF · Dental
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Quadrant Postericr Dense is a light curing dental composite filling material used in the adhesive restc rative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minir al invasive technique for maximal preservation of sound tooth tissue. Quadrant Posterior Dense is specifically designed for the restoration of posterior teeth, using the same application instruments and techniques as for dental amalgam.

Device Story

Quadrant Posterior Dense is a light-curing dental composite filling material. Used by dentists in clinical settings for restorative procedures on decayed posterior teeth. Applied using standard dental instruments and techniques similar to those used for dental amalgam. Material is placed into prepared cavities following adhesive dentistry principles, emphasizing minimal invasive techniques to preserve sound tooth tissue. Light-curing process hardens the composite to restore tooth structure and function.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-curing dental composite filling material. Designed for posterior tooth restoration. Formulated for use with adhesive restorative techniques.

Indications for Use

Indicated for the restoration of decayed posterior teeth using adhesive restorative techniques.

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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DEC 1 6 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bernard van Duijn Manging Technical Services Cavex Holland BV Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem (Holland)

Re : K984044 Trade Name: Quadrant Posterior Dense Regulatory Class: II Product Code: EBF Dated: November 11, 1998 November 13, 1998 Received:

Dear Mr. van Duijn:

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. 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 - Mr. Van Duijn

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 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 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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510(k) NUMBER (IF KNOWN): k984044

DEVICE NAME: Quadrant Posterior Dense

INDICATIONS FOR USE:

Quadrant Postericr Dense is a light curing dental composite filling material used in the adhesive restc rative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minir al invasive technique for maximal preservation of sound tooth tissue.

Quadrant Posterior Dense is specifically designed for the restoration of posterior teeth, using the same application instruments and techniques as for dental amalgam.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 8(1.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Susan Rumm

OR

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