CERCOM CEMENT

K083398 · Denali R&D Corporation · EMA · Jan 26, 2009 · Dental

Device Facts

• Record ID: K083398
• Device Name: CERCOM CEMENT
• Applicant: Denali R&D Corporation
• Product Code: EMA · Dental
• Decision Date: Jan 26, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

CERCOM Cement is a self-adhesive dental cement used for bonding ceramic and composite restorations. It is intended for professional use by dentists in a clinical setting. The device functions as a bonding agent to secure restorations to tooth structure. It is applied by the clinician during restorative dental procedures to improve the retention and stability of the restoration.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and composition comparison to predicate devices.

Technological Characteristics

Self-adhesive dental cement. Composition and physical properties are stated to be equivalent to predicate dental cements classified under 21 CFR 872.3275.

Indications for Use

Indicated for the bonding of 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 Cement (ESPE/3M)
• Variolink Cement (Ivoclar)
• Calibra Cement (Dentsply)
• Nexus Cement (Kerr)

Submission Summary (Full Text)

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K08 3398

## SUMMARY OF SAFETY AND E-FFECTIVENESS DATA

Dr Jan G Stannard 134 Old Washington Street Hanover, MA 02339-1629

DEVICE

Trade Name CERCOM Cement Classification Name Cement, Dental FDA Product Code 872 3275

781-826-9190 Telephone Fax [phone] | stannard@comcast net

JAN 2 6 2009

PREDICATE DEVICES RelyX Cement, ESPE/3M Variolink Cement, Ivoclar Calibra Cement, Dentsply Nexus Cement, Kerr

DESCRIPTION AND INTENDED USE

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

COMPARISON WITH PREDICATE PRODUCTS

CERCOM Cement is substantially equivalent in design, composition and intended use to the products listed above

SAFETY AND EFFECTIVENESS

CERCOM Cement is substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate cement products listed above

The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR EMA 872 3275

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr Jan G Stannard President Denalı R&D Corporation 134 Old Washington Street Hanover, Massachusetts 02339-1629

JAN 2 6 2009

Re K083398 Trade/Device Name CERCOM Cement Regulation Number 21 CFR 872 3275 Regulation Name Dental Cement Regulatory Class II Product Code EMA Dated November 12, 2008 Received November 17, 2008

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 affectung 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 vour 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone] Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 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,

Anthony D. Austin for
Ginette Y Michaud, M D

Acting 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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Image /page/3/Picture/1 description: The image shows the logo for Denali Corporation. The logo consists of a stylized mountain peak with a curved line above it, followed by the words "denali corporation" in a sans-serif font. The mountain peak is textured with a pattern of small lines, giving it a three-dimensional appearance.

## INDICATIONS FOR UST: STATEMENT

510 (k) Number _______________________________________________________________________________________________________________________________________________________________ (if known)

Device Name

CERCOM Cement

4683398

## Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

| 510(k) Number: | K08 3398 |
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| Prescription Use<br>(Per 21 CFR 801 109) | or | Over-The-Counter Use |
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