AURAVENEER CEMENT

K073101 · Denali Corporation · EMA · Jan 17, 2008 · Dental

Device Facts

• Record ID: K073101
• Device Name: AURAVENEER CEMENT
• Applicant: Denali Corporation
• Product Code: EMA · Dental
• Decision Date: Jan 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2

Intended Use

AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations.

Device Story

AURAVeneer Cement is a self-adhesive, light-cured, gel-like dental cement used for bonding ceramic and composite restorations. Composed of a hydrophilic resin and filler system, the material provides non-slumping handling characteristics to hold veneers in place during placement. It is applied by dental professionals in a clinical setting. The cement eliminates the need for separate bonding agents or silane coupling agents when bonding to dentin; enamel surfaces may require etching or micro-abrasion. By providing a stable, compatible interface between the tooth surface and the restoration, the device facilitates secure attachment of dental veneers, potentially improving clinical outcomes for restorative procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, composition, and performance characteristics compared to legally marketed predicate devices. The document cites general NIH assessment data regarding the high benefit-to-risk ratio of dental restorative materials.

Technological Characteristics

Self-adhesive, light-cured dental cement. Composition: hydrophilic resin and filler system. Form factor: gel-like, non-slumping. Shades: clear, enamel/white, dentin/yellow. Provided with corresponding try-in gels. No external bonding or silane coupling agents required.

Indications for Use

Indicated for bonding ceramic and composite dental 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.

Predicate Devices

• RelyX Veneer Cement, ESPE/3M
• Variolink Veneer Cement, Ivoclar
• Calibra, Dentsply
• Nexus, Kerr

Submission Summary (Full Text)

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K073101

510 (k) Premarket Notification AURAVeneer Cement

| | enali corporation | K073101 | 510 (k) Premarket Notification |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------|--------------------------------|
| | | | AURAVeneer Cement |
| | SUMMARY OF SAFETY AND EFFECTIVENESS DATA | | |
| Dr. Jan G. Stannard<br>134 Old Washington Street<br>Hanover, MA 02339-1629 | Telephone<br>Fax<br>[e-mail] | 781-826-9190<br>781-826-9190 | |
| DEVICE<br>Trade Name: AURAVeneer Cement<br>Classification Name: Cement, Dental<br>FDA Product Code: 872.3275 | | JAN 17 2008 | |
| PREDICATE DEVICES:<br>RelyX Veneer Cement, ESPE/3M<br>Variolink Veneer Cement, Ivoclar<br>Calibra, Dentsply<br>Nexus, Kerr | | | |
| DESCRIPTION AND INTENDED USE:<br>AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and<br>composite restorations. This veneer cement is made from a complimentary hydrophilic resin and<br>filler system, which creates compatibility between the tooth surface and restorative materials. AU-<br>RAVeneer Cement is a unique gel-like product that does not slump and will hold veneers in place<br>without drifting. AURAVeneer is a single component, light cured product. AURAVeneer is provided<br>in clear, enamel/white, and dentin/yellow shades. Corresponding try-in gels of the same colors are<br>also available. It is recommended that enamel surfaces, which are uncut, be etched or micro-<br>abraded to optimize bonding of this product to the dental surface. Etching or the use of bonding<br>agents when bonding to dentin is not required. Equally, the surface of the restoration should also<br>be pretreated to optimize bonding of the restoration. Bonding agents and silage coupling agents<br>are not required for the use of this product. | | | |
| COMPARISON WITH PREDICATE PRODUCTS:<br>AURAVeneer Cement is substantially equivalent in design, composition and intended use to the<br>products listed above. Please see page 12 for the entire comparison.<br>SAFETY AND EFFECTIVENESS:<br>AURAVeneer Cement is substantially equivalent in design, composition, performance, intended | | | |
| use and effectiveness to the predicate kit products listed above.<br>The predicate products have been found substantially equivalent under the 510(k) premarket<br>notification process as Class II Dental Devices under CFR EBC 872.3765, LBH 872.3260, and<br>EBF 872.3690. | | | |
| According to the NIH Technology Assessment conference on Effects and Side-Effects of Dental<br>Restorative Materials: "General usage of these materials over about 30 years indicates a high<br>benefit-to-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no<br>evidence of short-term or long-term risk...There is no suspicion of any problems after virtually bil-<br>lions of procedures in the United States. | | | |

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Public Health Service

JAN 17 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Jan G. Stannard President DENALI Corporation 134 Old Washington Street Hanover, Massachusetts 02339

Re: K073101

Trade/Device Name: AURAVeneer Cement Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: December 21, 2007 Received: January 3, 2007

Dear Dr. Stannard:

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 - Dr. Stannard

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,

Sude y Richmond.

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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enali corporation

INDICATIONS FOR USE STATEMENT

510 (k) Premarket Notification
AURAVeneer Cement

510 (k) Number
(if known)

Device Name

AURAVeneer Cement

Indications for Use:

AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and
composite restorations.

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Kunne

Prescription Use
(Per 21 CFR 801.109)
or
Over-The-Counter Use

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