EXCITE F AND EXCITE DSC

K093744 · Ivoclar Vivadent, Inc. · KLE · Mar 10, 2010 · Dental

Device Facts

• Record ID: K093744
• Device Name: EXCITE F AND EXCITE DSC
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: KLE · Dental
• Decision Date: Mar 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Excite® F is a light-curing, total etch, single component adhesive with fluoride release intended for use in clinical situations for: - Adhesive for direct light-curing and dual curing composite and compomer restorations - Adhesive for indirect all-ceramic and composite restorations (inlays, onlays, veneers; only light-curing) Excite® F DSC is a total etch, dual-curing and light curing adhesive with fluoride release intended for use in clinical situations for: - Adhesive cementation of indirect, metal-free, translucent restorations (e.g. IPS Empress CAD, IPS Empress Esthetic) with dual or self curing luting composites (e.g. Variolink II) - direct restorations and core build ups with dual and self curing compositions (e.g. Multicore) - Direct restorations/cementation with light-curing composites (e.g. Tetric EvoCeram, Variolink II Base, Heliomolar)

Device Story

Excite F and Excite F DSC are dental resin bonding agents designed for total-etch procedures. Excite F is a light-curing, single-component adhesive; Excite F DSC is a dual-curing adhesive. Both formulations incorporate fluoride release. Used by dental professionals in clinical settings to bond restorative materials—including composites, compomers, and indirect all-ceramic restorations—to tooth structure. The adhesive is applied to the prepared tooth surface to facilitate chemical and micromechanical retention of the restorative material. Benefits include improved marginal integrity and retention of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Total-etch, resin-based dental adhesive system. Excite F: light-curing, single-component. Excite F DSC: dual-curing (light and self-curing). Both contain fluoride-releasing components. Formulated for use with direct and indirect restorative materials including composites, compomers, and all-ceramic systems.

Indications for Use

Indicated for dental patients requiring adhesive bonding for direct light-curing/dual-curing composite and compomer restorations, indirect all-ceramic and composite restorations (inlays, onlays, veneers), and adhesive cementation of metal-free, translucent restorations. Contraindications not specified.

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 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Donna Marie Hartnett Director Quality Assurance/Regulatory Affairs Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

MAR 1 0 2010

Re: K093744

Trade/Device Name: Excite F & Excite F DSC Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 16, 2010 Received: February 22, 2010

Dear Ms. Hartnett:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Hartnett

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hh for

Anthony D. Watson, B.S.. M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known):

Device Name: Excite F & Excite F DSC Indications For Use:

Excite® F is a light-curing, total etch, single component adhesive with fluoride release intended for use in clinical situations for:

- Adhesive for direct light-curing and dual curing composite and compomer restorations

- Adhesive for indirect all-ceramic and composite restorations (inlays, onlays, veneers; only light-curing)

Excite® F DSC is a total etch, dual-curing and light curing adhesive with fluoride release intended for use in clinical situations for:

- Adhesive cementation of indirect, metal-free, translucent restorations (e.g. IPS Empress CAD, IPS Empress Esthetic) with dual or self curing luting composites (e.g. Variolink II)

- direct restorations and core build ups with dual and self curing compositions (e.g. Multicore)

- Direct restorations/cementation with light-curing composites (e.g. Tetric EvoCeram, Variolink II Base, Heliomolar)

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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Concurrence of CDRH, Office c

(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K09374 510(k) Number: __

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