XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE

K070538 · Dentsply Intl. · KLE · Mar 14, 2007 · Dental

Device Facts

• Record ID: K070538
• Device Name: XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
• Applicant: Dentsply Intl.
• Product Code: KLE · Dental
• Decision Date: Mar 14, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

XP BOND is indicated for 1 . Direct, Light-cured composite and compomer restorative. 2. Indirect Restorations; Light-cured, resin cemented Veneers. 3. Composite, ceramic and amalgam repairs. 4. Cavity varnish for use with fresh amalgam. 5. Direct, dual cure or self-cure composite restorations and core build-ups. 6. Indirect restorations; Dual cured and self-cured resin cemented inlays, onlays, crown and bridge retainers. 7. Dual cured and self cured resin cemented Endodontic post cementation. 8. Adhesive bonding of direct amalgam restoration.

Device Story

XP BOND Dual Cure is a universal self-priming dental adhesive system; used by dentists in clinical settings to bond resin-based materials to enamel, dentin, metals, and ceramics. Device functions as a bonding agent for direct and indirect restorative procedures; facilitates adhesion of composites, compomers, and cements. Applied by clinician to tooth structure or restoration surface; provides interface for restorative materials. Benefits patient by enabling secure attachment of dental restorations, improving longevity and structural integrity of repairs.

Clinical Evidence

Bench testing only. Biocompatibility testing performed, including Cytotoxicity and Ames Test, to confirm safety of components.

Technological Characteristics

Universal self-priming dental adhesive system. Components previously used in legally marketed dental devices. Biocompatibility confirmed via Cytotoxicity and Ames Test.

Indications for Use

Indicated for dental patients requiring adhesive bonding for direct/indirect restorations, including light-cured, dual-cure, or self-cure composites, compomers, veneers, inlays, onlays, crowns, bridges, endodontic posts, and amalgam repairs/bonding.

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.

Predicate Devices

• PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL ADHESIVE (K050386)

Submission Summary (Full Text)

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# SECTION 5: 510(k) SUMMARY

## MAR 1 4 2007

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|---------------------------------------------------------------------------|
| DATE PREPARED: | February 23, 2007 |
| TRADE OR PROPRIETARY NAME: | XP BOND Dual Cure Universal Total Etch<br>Adhesive |
| CLASSIFICATION NAME: | Agent, Tooth Bonding, Resin |
| REGULATION NUMBER: | 21CFR872.3200 |
| PRODUCT CODE: | KLE |
| PREDICATE DEVICES: | PRIME & BOND NT DUAL CURE NANO-<br>TECHNOLOGY UNIVERSAL ADHESIVE, K050386 |

DEVICE DESCRIPTION: The XP BOND Dual Cure is a universal self-priming dental adhesive system designed to bond resin based materials to enamel and dentin as well as to metals and ceramic.

INTENDED USE: XP BOND is indicated for

CONTACT:

- 1 . Direct, Light-cured composite and compomer restorative.
- 2. Indirect Restorations; Light-cured, resin cemented Veneers.
- 3. Composite, ceramic and amalgam repairs.
- 4. Cavity varnish for use with fresh amalgam.
- న్. Direct, dual cure or self-cure composite restorations and core build-ups.
- Indirect restorations; Dual cured and self-cured resin cemented inlays, onlays, crown and 6. bridge retainers.
- Dual cured and self cured resin cemented Endodontic post cementation. 7.
- 8. Adhesive bonding of direct amalgam restoration.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in XP BOND have been used in legally marketed devices and were found safe for dental use. XPBOND has been evaluated and passed biocompatibility testing for Cytotoxicity, Ames Test.

We believe that the prior use of the components of XP BOND in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of XP BOND for the indicated uses.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2007

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K070538

Trade/Device Name: XP BOND Dual Cure Universal Total Etch Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: February 23, 2007 Received: February 26, 2007

Dear Ms. Lewis:

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 - Ms. Helen Lewis

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/cdrb/industry/support/index.html.

Sincerely yours,

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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### SECTION 4: INDICATIONS FOR USE

# 1070538

510(k) Number (if known):

Device Name: XP BOND Dual Cure Universal Total Etch Adhesive

Indications for Use:

XP BOND is indicated for

- 1. Direct, Light-cured composite and compomer restorative.
- Indirect Restorations; Light-cured, resin cemented Veneers. 2.
- 3. Composite, ceramic and amalgam repairs.
- 4. Cavity varnish for use with fresh amalgam.
- 5. Direct, dual cure or self-cure composite restorations and core build-ups.
- Indirect restorations; Dual cured and self-cured resin cemented inlays, onlays, crown and 6. bridge retainers.
- Dual cured and self cured resin cemented Endodontic post cementation. 7.
- 8. Adhesive bonding of direct amalgam restoration.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runno

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