SET

K051008 · Southern Dental Industries, Ltd. · EMA · Jun 15, 2005 · Dental

Device Facts

• Record ID: K051008
• Device Name: SET
• Applicant: Southern Dental Industries, Ltd.
• Product Code: EMA · Dental
• Decision Date: Jun 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indirect cementation of ceramic, composite and metal inlays, onlays, crowns, bridges, posts, screws and veneers.

Device Story

Set is a dental cement used by dental professionals for the indirect cementation of various restorative materials, including ceramic, composite, and metal inlays, onlays, crowns, bridges, posts, screws, and veneers. The device is applied in a clinical setting to secure dental prosthetics to prepared tooth structures. It functions as a bonding agent to ensure the retention and stability of the restoration. The healthcare provider uses the cement during restorative procedures to improve patient outcomes by providing a durable interface between the tooth and the prosthetic device.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's classification as a dental cement and its intended use.

Technological Characteristics

Dental cement classified under 21 CFR 872.3275(b), Product Code EMA. The device is a chemical material used for the cementation of dental restorations.

Indications for Use

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

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

JUN 15 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ray Cahill Director, Sales and Marketing Southern Dental Industries, Incorporated 5-9 Brunsdon Street Bayswater, P.O. Box 314 Victoria 3153 AUSTRALIA

Re: K051008 Trade/Device Name: Set Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: June 06, 2005 Received: June 08, 2005

Dear Mr. Cahill:

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 Amendrants, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, or a concesting Act (Act) that do not require approval of a premarket approval application (PMA). Tou may, therefore, market the device, subject to the general controls provisions of the Act. To general controls provisions of the Act include requirements for annual registration, 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 an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mee publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Ray Cahill

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 complive ith 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 wour 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" (21 CFR 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.

Jenette y. Michael Davis.

Chiu S. Lin, PhD 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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510(k) Number (if known): K O5 j00 g

Device Name:

seT

´ Indications For Use:

Indirect cementation of ceramic, composite and metal inlays, onlays, crowns, bridges, posts, screws and veneers.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

-Counter Use:

(Division Sinr neral Hosnit: (Optional Format 1-2-96)

510(k) Number