SECURE

K073698 · Parkell, Inc. · EMA · Mar 19, 2008 · Dental

Device Facts

• Record ID: K073698
• Device Name: SECURE
• Applicant: Parkell, Inc.
• Product Code: EMA · Dental
• Decision Date: Mar 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

SEcure is a dual-cure, self-etching, adhesive dental cement system consisting of a self-etching primer and a two-part dental cement. The self-etching primer is supplied in a single bottle, while the dental cement is supplied in a double-barrel auto-mix syringe. The cement system does not require acid etching of tooth surfaces, and can be cured with any available curing light. The intended use of SEcure is for indirect cementation of porcelain, ceramic, resin and metalbased inlays, onlays, crowns, bridges, veneers and posts.

Device Story

SEcure is a dual-cure, self-etching, adhesive dental cement system used by dental professionals for the permanent cementation of indirect restorations. The system comprises a self-etching primer and a two-part dental cement delivered via a double-barrel auto-mix syringe. The self-etching chemistry eliminates the need for separate acid etching of tooth surfaces. The material is compatible with standard dental curing lights to initiate polymerization. By providing a reliable bond between the tooth structure and the restorative material (porcelain, ceramic, resin, or metal), the device secures inlays, onlays, crowns, bridges, veneers, and posts, thereby restoring dental function and aesthetics for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-cure, self-etching adhesive dental cement system. Components: single-bottle self-etching primer and double-barrel auto-mix syringe for the cement. Polymerization initiated via light-cure or chemical dual-cure mechanism. No specific material standards or software components described.

Indications for Use

Indicated for indirect cementation of porcelain, ceramic, resin, and metal-based inlays, onlays, crowns, bridges, veneers, 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

• TOTALBOND
• MAXCEM
• UNICEM

Submission Summary (Full Text)

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K073698

## 510(k) SUMMARY

| Submitter: | Parkell, Inc.<br>300 Executive Drive<br>Edgewood, NY 11717<br>TEL: [phone]<br>FAX: [phone] | MAR 19 2008 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Daniel R. Schechter, Esq.<br>General Counsel<br>Parkell<br>300 Executive Drive<br>Edgewood, NY 11717 | |
| Submission Date: | 28 December 2007 | |
| Trade Name: | SEcure | |
| Common Name: | Dental Cement | |
| Classification Name: | Dental Cement | |
| Equivalence: | TOTALBOND, MAXCEM, UNICEM | |
| Description/Intended Use: | SEcure is a dual-cure, self-etching, adhesive dental<br>cement system consisting of a self-etching primer and a<br>two-part dental cement. The self-etching primer is<br>supplied in a single bottle, while the dental cement is<br>supplied in a double-barrel auto-mix syringe. The<br>cement system does not require acid etching of tooth<br>surfaces, and can be cured with any available curing<br>light. The intended use of SEcure is for indirect | |

posts.

:

cementation of porcelain, ceramic, resin and metalbased inlays, onlays, crowns, bridges, veneers and

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 1 9 2008

Mr Daniel R. Schechter, Esq. Parkell, Incorporated 300 Executive Drive Edgewood, New York 11717

Re: K073698

Trade/Device Name: SEcure Adhesive Dental Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: December 28, 2007 Received: December 31, 2007

Dear Mr. Schechter:

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. Schechter

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 (OS) 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.

Susan Runner
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):

Ko73698

Device Name: SEcure Adhesive Dental Cement

Indications for Use:

SEcure Adhesive Dental Cement is a dual-cure, self-etching, adhesive dental cement system. It is intended for indirect cementation of porcelain, ceramic, resin, and metalbased inlays, onlays, crowns, bridges, veneers and posts.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Gunner

Division Sign-Off) ivision of Anesthesiology, General Hospital ntection Control, Dental Devices

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10(k) Number. K73658