SELF-ADHESIVE RESIN CEMENT

K073173 · Dentsply Interntional · EMA · Jan 23, 2008 · Dental

Device Facts

• Record ID: K073173
• Device Name: SELF-ADHESIVE RESIN CEMENT
• Applicant: Dentsply Interntional
• Product Code: EMA · Dental
• Decision Date: Jan 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.

Device Story

Self-adhesive Resin Cement is a dual-curing dental cement composed of base and catalyst pastes. It is supplied in double-barrel syringes or unit dose systems. Used by dental professionals in clinical settings for the permanent cementation of indirect restorations (inlays, onlays, crowns, bridges, posts). The cement is applied to the restoration or tooth surface, where it cures to provide adhesion. It benefits patients by securing indirect dental prosthetics.

Clinical Evidence

Bench testing only. Biocompatibility testing for cytotoxicity, genotoxicity, irritation, and sensitization was performed.

Technological Characteristics

Dual-curing resin cement consisting of base and catalyst pastes. Available in five shades. Delivered via double-barrel syringes or unit dose systems. Biocompatible materials consistent with legally marketed dental devices.

Indications for Use

Indicated for the cementation of indirect dental restorations, including ceramic, composite, and metal-based inlays, onlays, crowns, bridges, and posts.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Unicem (K020256)
• MaxCem (K041474)

Submission Summary (Full Text)

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K073173
510(k) SUMMARY

DENTSPLY Internation Susquehanna Commerce Center We 221 West Philadelphia Street, Suite ( York, PA 17405-08

| CONTACT: | Helen Lewis |
|----------------------------|-------------------------------------|
| DATE PREPARED: | November 8, 2007 |
| TRADE OR PROPRIETARY NAME: | Self-adhesive Cement |
| CLASSIFICATION NAME: | Dental cement, 21 CFR 872.3275 |
| PREDICATE DEVICES: | Unicem, K020256 and MaxCem, K041474 |

JAN 2 3 2008DEVICE DESCRIPTION: Self-adhesive Resin Cement consists of a base paste and a catalyst paste, mixed to form a dual-curing cement. The Cement is available in five shades and is delivered in double-barrel syringes and unit dose systems.

Unicem, K020256 and MaxCem, K041474

INTENDED USE:

Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in Self-adhesive Resin Cement have been used in legally marketed devices and/or were found safe for dental use. Self-adhesive Resin Cement has been evaluated and passed biocompatibility testing for cytotoxicity, genotoxicity, irritation and sensitization.

We believe that the prior use of the components of Self-adhesive Resin Cement in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of Self-adhesive Resin Cement for the indicated uses.

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JAN 23 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073173

Trade/Device Name: Self-Adhesive Resin Cement Regulation Number: 21 CFR 872.3275 (b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: November 8, 2007 Received: November 13, 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. 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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylite Y. Michie Davis.

Chiu Lin, Ph.D. 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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## INDICATIONS FOR USE

## 510(k) Number (if known):

Device Name: Self-adhesive Resin Cement

Indications for Use:

Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.

1073173

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K073173

Self-adhesive Resin Cement