NANO COMPOSITE

K070583 · Cosmedent, Inc. · EBF · Apr 16, 2007 · Dental

Device Facts

• Record ID: K070583
• Device Name: NANO COMPOSITE
• Applicant: Cosmedent, Inc.
• Product Code: EBF · Dental
• Decision Date: Apr 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NANO COMPOSITE is designed for Class I-V dental restorations, direct veneering of anterior teeth, splinting, and repair of composite or ceramic restorations.

Device Story

Cosmedent NANO COMPOSITE is a light-cure, nano-hybrid dental composite resin. Composed of difunctional acrylic monomers and silicaceous fillers; material mimics natural tooth appearance. Supplied in preloaded, plastic-screw fed syringes. Clinician extrudes material onto pad, places into prepared cavity, and light-cures. Used in dental clinics for restorative procedures. Output is a hardened, esthetic dental restoration. Benefits include structural repair and esthetic improvement of teeth.

Clinical Evidence

Bench testing only. Comparison of physical and mechanical properties provided, including compressive strength (400 MPa vs 313 MPa), flexural strength (125 MPa vs 120 MPa), and modulus of elasticity (12000 MPa vs 9500 MPa). Both devices are radiopaque.

Technological Characteristics

Nano-hybrid dental composite. Materials: difunctional acrylic monomers, silicaceous fillers. Energy source: light-cure. Form factor: preloaded, plastic-screw fed syringes. Radiopaque. No software or electronic components.

Indications for Use

Indicated for patients requiring Class I-V dental restorations, direct anterior tooth veneering, splinting, or repair of existing composite or ceramic restorations.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Tetric EvoCeram (K042819)

Submission Summary (Full Text)

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K070583

Cosmedent, Inc. 401 N. Michigan Ave., Ste 2500, Chicago, IL 60611 510(k) submission for NANO COMPOSITE

Page 17 of 23

APR 16 2007

#### 510(k) SUMMARY

As required by the Safe Medical Devices Act of 1990

## .DESCRIPTION OF THE APPLICANT DEVICE

TRADE NAME: Multiple (NANO COMPOSITE)

.. .

COMMON NAME: Nano-hybrid Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF)

Cosmedent NANO COMPOSITE is a light-cure composite resin fabricated from difunctional acrylic monomers and silicaceous fillers. These materials possess physical and mechanical properties that allow them to function in the oral cavity with esthetic qualities that mimic natural tooth appearance.

The technological characteristics of the applicant device are essentially identical to the predicate device.

### IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

TRADE NAME: Tetric EvoCeram COMMON NAME: Nano-hybrid Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF) 510(k) Number: K042819

| EQUIVALENTS | Cosmedent<br>NANO COMPOSITE | Ivoclar Vivadent<br>TETRIC EVO CERAM |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| | Similarities | |
| Intended Use | Both products have identical intended uses as esthetic dental<br>restorative materials | |
| Composition | Both products have substantially the same chemical composition.<br>They are light-cure, silica filled, difunctional acrylic composites | |
| Physical properties | Both products have similar physical and mechanical properties as<br>shown below | |
| How supplied and used | Both products are supplied as preloaded, plastic-screw fed syringes.<br>The material is extruded onto a suitable pad and placed in the<br>prepared cavity and light cured | |
| Mechanical and Physical Properties | Cosmedent<br>NANO COMPOSITE | Ivoclar Vivadent<br>TETRIC EVOCERAM |
| Compressive strength | 400 MPa | 313 MPa |
| Flexural strength | 125 MPa | 120 MPa |
| Modulus of elasticity | 12000 MPa | 9500 MPa |
| Radiopaque | Yes | Yes |
| | Differences | |
| Number of shades | 13 | 16 |

#### SUBSTANTIAL EQUIVALENCE SUMMARY

Submitted by: James L. Sandrik, PhD Cosmedent, Inc. 401 N. Michigan Ave. Suite 2500 Chicago, IL 60611

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right and appears to be in flight. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

James L. Sandrik, PhD Director of Regulatory Affairs Cosmedent, Incorporated 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611

APR 1 6 2007

Re: K070583

Trade/Device Name: Nano Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 28, 2007 Received: March 01, 2007

Dear Dr. Sandrik:

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 Amendrants, 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 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 mey publish further announcements concerning your device in the Federal Register.

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Page 2 - James L. Sandrik, PhD

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" (21 CFR 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.

Syria Y. Michael M.D.

Chiu S. Lin. PhD 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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Page 4 of 23

# INDICATIONS FOR USE

510(k) Number (if known):

K070583

Device Name: MULTIPLE (NANO COMPOSITE)

Indication For Use:

NANO COMPOSITE is designed for Class I-V dental restorations, direct veneering of anterior teeth, splinting, and repair of composite or ceramic restorations.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Soares

Production POSCH 3 Jon Connell,

(k) Number