SYSTEMP.CEM

K042847 · Ivoclar Vivadent, Inc. · EMA · Dec 17, 2004 · Dental

Device Facts

• Record ID: K042847
• Device Name: SYSTEMP.CEM
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EMA · Dental
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

For the temporary cementation of provisional restorations; temporary cementation of provisional crowns and bridges; and for the temporary cementation of restorations during the healing phase. The product has been designed to remain in the mouth for up to 4 weeks.

Device Story

Systemp.cem is a dental cement used for temporary fixation of provisional restorations (crowns/bridges) and during healing phases. Applied by dental professionals in a clinical setting. Material provides temporary adhesion to tooth structure and restoration surfaces; allows for easy removal of provisional restorations after up to 4 weeks. Benefits include secure temporary retention and protection of prepared teeth during the interim period before final restoration placement.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental cement for temporary restoration fixation. Formulated for intraoral use with a 4-week duration limit. Class II device under 21 CFR 872.3275.

Indications for Use

Indicated for temporary cementation of provisional dental restorations, including crowns and bridges, and for use during healing phases. Designed for intraoral use for up to 4 weeks.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border. In the center of the seal is a stylized eagle-like symbol with three curved lines representing the wings and body. The seal is black and white and appears to be a logo or emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

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

Re: K042847

Trade/Device Name: Systemp.cem Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 12, 2004 Received: October 15, 2004

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.

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 (1 vir 1), it an 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 Eederal 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 moan that I Drimas made a and regulations administered by other Federal agencies. or the Act of all - Pocchal the Act's requirements, including, but not limited to: registration r our must compry with and and many (21 CFR Part 801); good manufacturing practice and listing (21 er result in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as betrenir 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) rms reter notification. The FDA finding of substantial equivalence of your device to a promation noticated 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), 11 you desire specific at no roompliance 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/dsma/dsmamain.html

Sincerely yours,

Cule

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: Systemp.cem Indications For Use:

## Intended Use:

intended Ose:
For the temporary cementation of provisional restorations; temporary cementation of r or the temporary ochiontaker an phase. The product has been designed to remain in the mouth for up to 4 weeks.

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

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

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(Division Sign-Off)

Division of Anesthesiology, General Hospital,

Infection Control, Dental Devices

| 510(k) Number: | K0412847 |
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