QUADRANT UNICHEM

K983751 · Cavex Holland BV · EBF · Nov 30, 1998 · Dental

Device Facts

• Record ID: K983751
• Device Name: QUADRANT UNICHEM
• Applicant: Cavex Holland BV
• Product Code: EBF · Dental
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Quadrant UniChem is a two component, self-curing curing dental composite filling material, including an etching agent (Quadrant Total Etch) and a two component, selfcuring enamel bonding agent, used in the adhesive restorative technique for the restoration of decayed teeth. Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue. Quadrant UniChem is a composite for universal use: the restoration of both anterior and posterior teeth. It can also be used for core build-up: the reconstruction of a tooth with insufficient material left as a result of decay, before crown preparation.

Device Story

Quadrant UniChem is a two-component, self-curing dental composite filling material. It includes an etching agent (Quadrant Total Etch) and a two-component, self-curing enamel bonding agent. Used by dentists in clinical settings for adhesive restorative techniques. The device is applied to prepared tooth cavities to restore decayed tooth structure or perform core build-ups. It functions via chemical self-curing to harden the composite material within the tooth cavity, facilitating the reconstruction of tooth tissue.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Two-component, self-curing dental composite material; includes etching agent and enamel bonding agent; chemical curing mechanism; universal application for anterior and posterior teeth.

Indications for Use

Indicated for restoration of decayed anterior and posterior teeth and core build-up prior to crown preparation in patients requiring dental restorative procedures.

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

NOV 30 1998

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

K983751 Re : Quadrant Unichem Trade Name: Regulatory Class: II Product Code: EBF October 20, 1998 Dated: October 23, 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, Druq, 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 aqainst 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 requlations 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 requlation 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 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 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.fdaflgov/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): K9837S I

DEVICE NAME: Quadrant UniChem

INDICATIONS FOR USE:

Quadrant UniChem is a two component, self-curing curing dental composite filling material, including an etching agent (Quadrant Total Etch) and a two component, selfcuring enamel bonding agent, used in the adhesive restorative technique for the restoration of decayed teeth.

Cavity preparation is performed according to the principles of adhesive dentistry, adopting the minimal invasive technique for maximal preservation of sound tooth tissue.

Quadrant UniChem is a composite for universal use: the restoration of both anterior and posterior teeth. It can also be used for core build-up: the reconstruction of a tooth with insufficient material left as a result of decay, before crown preparation.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) Sandra L. Stine for L. Rummer (Optional Format 1-2-96)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K983751