SYSTEMP.LINK

K042846 · Ivoclar Vivadent, Inc. · EMA · Dec 20, 2004 · Dental

Device Facts

• Record ID: K042846
• Device Name: SYSTEMP.LINK
• Applicant: Ivoclar Vivadent, Inc.
• Product Code: EMA · Dental
• Decision Date: Dec 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the temporary cementation of temporary inlays, partial crowns, crowns or bridges. The retention period should not last longer than 8 weeks.

Device Story

Systemp.link is a dental cement used for temporary fixation of provisional restorations (inlays, partial crowns, crowns, bridges). Applied by dental professionals in a clinical setting; provides temporary retention for up to 8 weeks. Facilitates easy removal of temporary restorations without damaging the underlying tooth structure. Benefits patient by maintaining function and aesthetics during the interim period between preparation and final restoration placement.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Dental cement (Product Code: EMA) classified under 21 CFR 872.3275. Material properties and performance characteristics are consistent with established standards for temporary dental luting agents.

Indications for Use

Indicated for temporary cementation of temporary inlays, partial crowns, crowns, or bridges for a retention period not exceeding 8 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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 20 2004

Ms. Donna M. Hartnett Director of QA/RA and Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K042846

Trade/Device Name: Systemp.link Regulation Number: 21 CFR 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 vour 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. 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 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/dsma/dsmamain.html

Sincerely yours,

Susan Runne

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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):__ Ko 4 2846

Device Name: Systemp.link Indications For Use:

## Intended Use:

interitued USC:
For the temporary cementation of temporary inlays, partial crowns, crowns or bridges. The retention period should not last longer than 8 weeks.

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

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

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| Division of Anesthesiology, General Hospital,<br>Infection Control, Dental Devices | | |
| 510(k) Number | K042846 | |