QUADRANT UNIBOND

K983545 · Cavex Holland BV · KLE · Nov 18, 1998 · Dental

Device Facts

• Record ID: K983545
• Device Name: QUADRANT UNIBOND
• Applicant: Cavex Holland BV
• Product Code: KLE · Dental
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Quadrant UniBond is used in the adhesive restorative technique for bonding of dental composite restorations to tooth tissue and for sealing of exposed root surfaces. Quadrant UniBond is used in the so-called "total etch technique", in combination with an etching agent such as Quadrant Total Etch. Conditioning of the enamel and dentin with this technique will enable the bonding agent to penetrate and seal off the cavity wall, thus forming an adhesive layer for the composite filling material.

Device Story

Quadrant UniBond is a dental adhesive system used by dentists in clinical settings. It functions as a bonding agent in the total etch technique; applied to enamel and dentin after etching with an agent like Quadrant Total Etch. The material penetrates and seals cavity walls, creating an adhesive layer for composite filling materials. It also seals exposed root surfaces. The device is applied manually by the clinician during restorative procedures to improve the retention and marginal integrity of dental composites.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental adhesive bonding agent; liquid form for application to tooth tissue; used in conjunction with etching agents; chemical composition designed for enamel/dentin penetration and sealing.

Indications for Use

Indicated for dental patients requiring adhesive bonding of composite restorations to tooth tissue and sealing of exposed root surfaces using a total etch technique.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Reference Devices

• Quadrant Total Etch

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

NOV 1 8 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K983545 Quadrant UniBond Trade Name: Requlatory Class: II Product Code: KLE October 6, 1998 Dated: October 9, 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, qood 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. ਕੇ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. 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 described in your alone of your device to a legally Finding of subbeaneral squareults in a classification for your marketca predicatoremits 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 compriation 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 premation on your responsibilities under the Act may be Intoimation of Journall Manufacturers Assistance obcation from one [phone] or [phone] or at at its coll free namber (0:1)/www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Direct Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K983545

Page 1 of 1

510(k) NUMBER (IF KNOWN) :

DEVICE NAME: Quadrant UniBond

INDICATIONS FOR USE:

Quadrant UniBond is used in the adhesive restorative technique for bonding of dental composite restorations to tooth tissue and for sealing of exposed root surfaces.

Quadrant UniBond is used in the so-called "total etch technique", in combination with an etching agent such as Quadrant Total Etch. Conditioning of the enamel and dentin with this technique will enable the bonding agent to penetrate and seal off the cavity wall, thus forming an adhesive layer for the composite filling material.

(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)

OR

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

Susan Runner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K983545