RIVA LUTING

K040393 · Southern Dental Industries, Inc. · EMA · Apr 30, 2004 · Dental

Device Facts

• Record ID: K040393
• Device Name: RIVA LUTING
• Applicant: Southern Dental Industries, Inc.
• Product Code: EMA · Dental
• Decision Date: Apr 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Suitable for cementation of crowns, bridges, inlays and orthodontic bands. Also suitable for sealing interface between restoration and tooth and base / liner in deep restorations.

Device Story

Riva Luting is a dental cement used by dental professionals for the permanent cementation of crowns, bridges, inlays, and orthodontic bands. It also functions as a sealant for the interface between dental restorations and tooth structure, and as a base or liner for deep restorations. The device is applied by a clinician in a dental office setting. It facilitates the mechanical retention and sealing of dental prosthetics, potentially improving the longevity of the restoration and protecting the underlying tooth structure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental cement (Product Code: EMA). Class II device per 21 CFR 872.3275.

Indications for Use

Indicated for cementation of crowns, bridges, inlays, and orthodontic bands; sealing the interface between restoration and tooth; and use as a base/liner in deep restorations.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 symbol that resembles an eagle or bird with three wing-like shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2004

Ms. Samantha J. Cheetham Official Correspondent Southern Dental Industries, Incorporated 729 N. Route 83. Suite 315 Bensenville, Illinois 60106

Re: K040393

Trade/Device Name: Riva Luting Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 15, 2004 Received: February 17, 2004

Dear Ms. Cheetham:

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 - Ms. Cheetham

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 cntitled, "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,

Chiu-Ling, Ph.D.

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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510(k) Number (if known):

Device Name:

Indications For Use:

K040393

Riva Luting

Suitable for cementation of crowns, bridges, inlays and orthodontic bands.

Also suitable for sealing interface between restoration and tooth and base / liner in deep restorations.

Robert Betz DDS for Dr. Susan Reumer
(Division Sign-Off)
Division of Anesthesiology, General How
Infection Cont

fection Control, Dental Devices by General Hospital,
510(k) Number K040392

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: _ (Par 71 CFR 801.109) OR

Over-The-Counter Use: _______________________________________________________________________________________________________________________________________________________

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