QUADRANT UNIT-1-BOND
Device Facts
| Record ID | K042806 |
|---|---|
| Device Name | QUADRANT UNIT-1-BOND |
| Applicant | Cavex Holland BV |
| Product Code | KLE · Dental |
| Decision Date | Nov 24, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3200 |
| Device Class | Class 2 |
Indications for Use
Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.
Device Story
Quadrant Uni-1-Bond is a light-curing, single-component, ethanol-based dental adhesive resin. Used by dentists in clinical settings to prime and bond restorative materials to tooth structure in a single step. Applied to prepared tooth surfaces and cured via light activation to facilitate adhesion of restorative materials. Benefits include simplified application process and universal compatibility with adhesive restorations.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Ethanol-based formulation of light-activated adhesive resins. Single-component, light-curing system. Class II dental device.
Indications for Use
Indicated for use as a light-curing, single-component bonding agent for adhesive dental restorations. Used by dental professionals for priming and bonding in a single step.
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.
Submission Summary (Full Text)
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 2004
Mr. Richard Woortman Manager, Technical Services Cavex Holland BV Harmenjansweg 19-21 P.O. Box 852 2003 RW Haarlem THE NETHERLANDS
Re: K042806
Trade/Device Name: Ouadrant Uni-1-Bond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: October 07, 2004 Received: October 13, 2004
Dear Mr. Woortman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu S. Lin, Ph.D.
Chiu S. Lin. PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN) : K 04-29 06 DEVICE NAME: Quadrant Uni-1-Bond
INDICATIONS FOR USE:
Quadrant Uni-1-Bond is a light curing, single component bonding agent for universal use in combination with adhesive restorations. Quadrant Uni-1-Bond primes and bonds in one step. Quadrant Uni-1-Bond is an ethanol-based formulation of lightactivated, adhesive resins.
(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)
Clubs
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic
510(k) Number: K042806
