ADHESIVE DC ACTIVATOR

K062713 · Ivoclar Vivadent, Inc. · KLE · Nov 2, 2006 · Dental

Device Facts

• Record ID: K062713
• Device Name: ADHESIVE DC ACTIVATOR
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: KLE · Dental
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Indications for Use

Adhesive cementation of indirect meal-free restorations (inlays, onlays, crowns, bridges or of metal free posts with dual or self curing composites. Direct restorations and core build-ups with dual and self curing composites.

Device Story

AdheSE DC Activator is a dental bonding agent component used by dentists in clinical settings. It functions as an activator for dual- or self-curing composite materials. The device is applied during the cementation of indirect metal-free restorations (inlays, onlays, crowns, bridges) or posts, and during direct restorations or core build-ups. By facilitating the curing process of the composite, it ensures proper bonding of the restoration or build-up material to the tooth structure. The clinician applies the activator to the composite material to initiate or accelerate polymerization, resulting in a stable, bonded dental restoration. This process benefits the patient by providing secure, durable retention of dental prosthetics and restorative materials.

Clinical Evidence

Bench testing only.

Technological Characteristics

Resin tooth bonding agent (21 CFR 872.3200). Chemical activator for dual- or self-curing composite materials. Class II device.

Indications for Use

Indicated for adhesive cementation of indirect metal-free restorations (inlays, onlays, crowns, bridges) or metal-free posts using dual or self-curing composites, and for direct restorations and core build-ups using dual or self-curing composites.

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

Mr. Anderjeet S. Gulati Regulatory Affairs Manager Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

NOV - 2 2006

Re: K062713

Trade/Device Name: AdheSE® DC Activator Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 06, 2006 Received: September 18, 2006

Dear Mr. Gulati:

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 Federal Register.

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Page 2 - Mr. Anderjeet S. Gulati

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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours.

Clus

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): | Not Yet Assigned k062713 |
|---------------------------|--------------------------|
|---------------------------|--------------------------|

Device Name:

AdheSE DC Activator®

Indications For Use:

Adhesive cementation of indirect meal-free restorations (inlays, onlays, crowns, bridges or of metal free posts with dual or self curing composites.

Direct restorations and core build-ups with dual and self curing composites.

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Concurrence of CDRH, Office of Device Evaluation (ODE)


on of Anesthesiology, General Hospital,

Jun Control, Dental Devices

| Prescription Use <b>X</b> (Per 21 CFR 801.109) | K062713 | Over-The-Counter Use ___ |
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