COSMEDENT BRUSHABLE COMPOSITE

K092730 · Cosmedent, Inc. · EBF · Nov 20, 2009 · Dental

Device Facts

• Record ID: K092730
• Device Name: COSMEDENT BRUSHABLE COMPOSITE
• Applicant: Cosmedent, Inc.
• Product Code: EBF · Dental
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, appiration of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.

Device Story

Brushable Composite is a low-viscosity, light-cure, silica-filled, difunctional acrylic composite used by dental professionals in clinical settings. Supplied in preloaded plastic syringes, the material is extruded onto a pad or well and applied to instruments to facilitate the sculpting and placement of esthetic dental restorative materials. It assists in direct veneering, splinting, and repair of composite restorations, particularly when the air-inhibited surface of a previous layer requires modification. By improving the handling and manipulation of restorative composites, the device enables precise placement and shaping, ultimately benefiting the patient through improved restoration aesthetics and structural integrity.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cure, silica-filled, difunctional acrylic composite; low-viscosity microfilled formulation; 36% filler content; supplied in preloaded plastic syringes.

Indications for Use

Indicated for dental professionals to facilitate application of composite restorative materials, assist in direct veneering of anterior teeth, splinting, and repair of composite restorations, including layering applications.

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

• Bisco SCULPTING RESIN (K030585)

Submission Summary (Full Text)

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K092730

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

Page 13 of 14

#### REVISED

#### 510(k) SUMMARY

NOV 2 0 2009

As required by the Safe Medical Devices Act of 1990

### DESCRIPTION OF THE APPLICANT DEVICE

TRADE NAME: BRUSHABLE COMPOSITE COMMON NAME: Brushable Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF)

Indications for Use: Cosmedent BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, splinting, appiration of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.

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

# IDENTIFICATION OF THE LEGALLY MARKETED PREDICATE DEVICE

TRADE NAME: Bisco SCULPTING RESIN COMMON NAME: Brushable Dental Composite CLASSIFICATION NAME: Tooth Shade Resin Material (21 CFR 872.3690, Product code EBF) 510(k) Number: K030585

| EQUIVALENTS | Cosmedent<br>BRUSHABLE<br>COMPOSITE | Bisco Sculpting Resin |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Similarities | | |
| Intended Use | Both products are intended to be used to manipulate and<br>sculpt esthetic dental restorative materials | |
| Composition | Both products have substantially the same chemical<br>composition. They are light-cure, silica filled,<br>difunctional acrylic composites | |
| Physical/mechanical Aspects | Both products are low viscosity microfilled composites<br>and have similar physical and mechanical properties | |
| How supplied and used | Both products are supplied as preloaded, plastic<br>syringes. The material is extruded onto a suitable pad or<br>well and applied to the instrument | |
| Differences | | |
| Filler percentage | 36% | 30% |

#### 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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

. . . . . . .

## NOV 2 0 2009

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

Re: K092730

Trade/Device Name: Brushable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 3, 2009 Received: November 4, 2009

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 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 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. Sandrik

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K092730

Cosmedent, Inc., 401 N. Michigan Ave., Suite 2500 _60611 510(k) submission for BRUSHABLE COMPOSITE Page 4 of 14

## REVISED

### INDICATIONS FOR USE

510(k) Number (if known):

Device Name: MULTIPLE (BRUSHABLE COMPOSITE)

Indication For Use:

BRUSHABLE COMPOSITE is used to facilitate the brush/instrument application of dental composite restorative materials; to assist in direct veneering of anterior teeth, achinting, and repair of composite restorations. BRUSHABLE COMPOSITE may be used during layering especially if the air-inhibited surface has been affected.

× 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)

Kein Muluy for Mise

(Division Sign-Off)

· Mision of Anesthesiology, General Hospital infection Control. Dental Devices

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