RIVA BOND LC

K062064 · Southern Dental Industries, Inc. · EMA · Nov 9, 2006 · Dental

Device Facts

• Record ID: K062064
• Device Name: RIVA BOND LC
• Applicant: Southern Dental Industries, Inc.
• Product Code: EMA · Dental
• Decision Date: Nov 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For direct bonding of composite resin to dentin and enamel. For direct bonding of composite resin to dentin and enamel in the co-cured technique. For direct bonding of composite resin to GI self cure or GI light cure base base base on and enamel in the "sandwich" technique. For sealing to hypersensitive cervical areas and root surfaces of teeth.

Device Story

Riva Bond LC is a dental adhesive system used by dentists in clinical settings. It functions as a bonding agent to facilitate the adhesion of composite resin restorative materials to tooth structures (dentin and enamel). It is also indicated for sealing hypersensitive cervical areas and root surfaces. The device is applied by the clinician to the prepared tooth surface to create a bond interface. It serves to improve the retention of composite restorations and reduce sensitivity in exposed root surfaces. The clinical benefit is the successful restoration of tooth structure and management of dentinal hypersensitivity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured dental adhesive system. Formulated for bonding composite resin to dentin/enamel and sealing root surfaces. Class II medical device (Product Code: EMA).

Indications for Use

Indicated for direct bonding of composite resin to dentin and enamel, including co-cured and sandwich techniques with GI bases, and for sealing hypersensitive cervical areas and root surfaces.

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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Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2008

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

Re: K062064 Trade/Device Name: Riva Bond LC Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 30, 2006 Received: November 6, 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. Incall that I DA mas made a wees and regulations administered by other Federal agencies. of the Act of ally I ederal station and sequirements, including, but not limited to: registration 1 ou intist contiply with and 107); labeling (21 CFR Part 801); good manufacturing practice and ilsting (21 CF R Parvov), arrality systems (QS) regulation (21 CFR Part 820); and if requirements us bet form arrative tradiation 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), 11 you don't 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 vours,

Suyite Y. Michaud.

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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K062064

Page 1 of 1

510(k) Number (if known):

Device Name:

Indications For Use:

Kole 204

Riva Bond LC

- · For direct bonding of composite resin to dentin and enamel.
- · For direct bonding of composite resin to dentin and enamel in the co-cured technique.
- · For direct bonding of composite resin to GI self cure or GI light cure base base base on and enamel in the "sandwich" technique.
- · For · sealing to hypersensitive cervical areas and root surfaces of teeth.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
|----------------------------------------------------------------------------------|---------|
| 510(k) Number: | K062061 |

| Prescription Use: | <div style="display:inline-block; width:20px; border-bottom: 1px solid black;">/</div> | OR | Over-The-Counter Use: | <div style="display:inline-block; width:20px; border-bottom: 1px solid black;"></div> |
|----------------------|----------------------------------------------------------------------------------------|----|--------------------------|---------------------------------------------------------------------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) | |