TEMPORARY RESIN CEMENT

K031212 · Parkell, Inc. · EMA · Jul 11, 2003 · Dental

Device Facts

• Record ID: K031212
• Device Name: TEMPORARY RESIN CEMENT
• Applicant: Parkell, Inc.
• Product Code: EMA · Dental
• Decision Date: Jul 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A resin-based cement designed for use with provisional restorations such as crowns, inlays, fixed bridges, etc. or for temporary cementation of permanent restorations.

Device Story

Temporary Resin Cement is a radiopaque, self-cure, resin-based dental material. It is used by dental professionals in a clinical setting to lute provisional restorations (crowns, inlays, onlays, fixed bridges, laminate veneers) or to temporarily cement permanent restorations. The device functions as a chemical adhesive to secure dental prosthetics during the interim period before final cementation. It provides a temporary bond that allows for later removal of the restoration by the clinician.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiopaque, self-cure, resin-based dental cement. Formulated for temporary luting of dental restorations. Class II device under 21 CFR 872.3275(b).

Indications for Use

Indicated for luting provisional dental restorations (crowns, inlays, fixed bridges) or temporary cementation of permanent dental restorations in patients requiring temporary fixation.

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

• TempBond Clear
• Sensitemp
• GC Temporary Cement

Submission Summary (Full Text)

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JUL 1 1 2003

최고 대표 사

K031212

## 510(k) SUMMARY

| Submitter: | Parkell, Inc.<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735<br>TEL: [phone]<br>FAX: [phone] |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nelson J. Gendusa, DDS<br>Director of Research<br>Parkell<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735 |
| Submission Date: | 15 April 2003 |
| Trade Name: | Currently Not Available |
| Common Name: | Temporary Cement |
| Classification Name: | Cement, Dental (other than zinc oxide-eugenol) |
| Equivalence: | TempBond Clear, Sensitemp, GC Temporary Cement. |
| Description/Intended Use: | A radiopaque, self-cure, resin-based temporary cement<br>that is used to lute provisional restorations such as<br>crowns, inlays, onlays, fixed bridges, laminate veneers,<br>etc. or to temporarily cement permanent dental<br>restorations. |

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a series of flowing lines.

Public Health Service

JUL 1 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nelson J. Gendusa, DDS Director of Research Parkell, Inccorporated 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735

Re: K031212

Trade/Device Name: Temporary Resin Cement Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA Dated: April 15, 2003 Received: April 17, 2003

Dear Dr. Gendusa:

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 - Nelson J. Gendusa, DDS

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Susan Rinne/

Susan Runner, DDS, MA Interim 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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| 510(k) Number (if known):_ | | |
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| TEMPORARY RESIN CEMENT (12-9-1/2)<br>Device Name: | | |
| Indications for Use: | A resin-based cement designed for use with provisional restorations such as crowns, inlays,<br>fixed bridges, etc. or for temporary cementation of permanent restorations. | |
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| | Son MSG7<br>(Division Sign-Off)<br>Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices<br>K 031212<br>510(k) Number: __ | |

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