RIVA LUTING PLUS

K062065 · Southern Dental Industries, Inc. · EMA · Nov 15, 2006 · Dental

Device Facts

• Record ID: K062065
• Device Name: RIVA LUTING PLUS
• Applicant: Southern Dental Industries, Inc.
• Product Code: EMA · Dental
• Decision Date: Nov 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cementation of metal free or porcelain fused to metal inlays, onlays, bridges and crowns. Cementation of stainless steel crowns. Cementation of posts and screws. Attachment of metal orthodontic bands. Base or liner.

Device Story

Riva Luting Plus is a dental cement used by dental professionals for the permanent fixation of various prosthetic restorations and orthodontic appliances. It functions as a luting agent for crowns, bridges, inlays, onlays, posts, and screws, and serves as a base or liner under restorations. The device is applied by a clinician in a dental office setting. It provides mechanical and chemical retention between the tooth structure and the restorative material, aiding in the stabilization and long-term success of dental prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin-modified glass ionomer dental cement. Supplied as a multi-component system for mixing. Class II medical device (Product Code: EMA).

Indications for Use

Indicated for dental cementation procedures including metal-free or porcelain-fused-to-metal inlays, onlays, bridges, and crowns; stainless steel crowns; posts and screws; metal orthodontic bands; and use as a base or liner.

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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NOV 1 5 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ray Cahill Technical Director Southern Dental Industries, Incorporated 729 North Route 83, Suite 315 Bensenville, Illinois 60106

Re: K062065

Trade/Device Name; Riva Luting Plus Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 27, 2006 Received: October 30, 2006

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 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 - Mr. 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 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/industry/support/index.html.

Sincerely yours,

Susite y. Micee DmD

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:

Riva Luting Plus

- · Cementation of metal free or porcelain fused to metal inlays, onlays, bridges and crowns. 、
- · Cementation of stainless steel crowns.
- · Cementation of posts and screws.
- Attachment of metal orthodontic bands.
- · Base or liner.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:
(Per 21 CFR 801.109)

OR

(Sign Off)

Over-The-Counter Use: **__**
(Optional Format 1-2-96)

Ioa of Anesthesiology, General Hospital,
on Control, Dental Devices

ber. Korados