RENAMEL SCULPT

K993658 · Cosmedent, Inc. · EBF · Jan 18, 2000 · Dental

Device Facts

• Record ID: K993658
• Device Name: RENAMEL SCULPT
• Applicant: Cosmedent, Inc.
• Product Code: EBF · Dental
• Decision Date: Jan 18, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Renamel Scuptable Composite is used in Class II , Class V Restorations and to build up the lingual wall on Class IV anterior restorations.

Device Story

Renamel Sculpt is a light-cured composite restorative material system; used by dental professionals for Class II and Class V restorations and lingual wall build-up in Class IV anterior restorations. The material is applied to the tooth structure and cured using a dental light source to restore form and function. It serves as a restorative dental material to replace missing tooth structure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured composite restorative material system. Chemical composition details are proprietary.

Indications for Use

Indicated for patients requiring Class II and Class V dental restorations and build-up of the lingual wall for Class IV anterior 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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare. The symbol is composed of three curved lines that converge at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 18 2000

Mr. Michael O'Malley President Cosmedent®, Inc. 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611

K993658 Re : Renamel Sculpt Trade Name: Requlatory Class: II Product Code: EBF Dated: January 5, 1999 Received: January 5, 1999

Dear Mr. O'Malley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal_Register. Please note: this response to your premarket notification submission does not affect any

{1}------------------------------------------------

Page 2 - Mr. O'Malley

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence reads 'K993658'. The characters and numbers are written in a bold, black font, which makes them stand out against the white background. The handwriting style appears somewhat informal.

## INDICATIONS FOR USE STATEMENT

510(K) Number (if known):

K993658

Device Name:

Renamel Sculpt

Indication for Use:

Renamel Scuptable Composite is used in Class II , Class V Restorations and to build up the lingual wall on Class IV anterior restorations.

## DESCRIPTION OF DEVICE

Renamel Sculpt Composite is a system consisting of light cured composite restorative materials.

A confidential chemical analysis of Renamel Pack Composite may be found in Appendix B.

## (PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)
*Susan Purdy*

| (Division Sign-Off) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K993658 |

| Prescription Use | <div> <svg height="15" width="15"> <path d="M3 7 L7 11 L12 4" fill="none" stroke="black"></path> </svg> </div> | OR | Over-the Counter Use | |
|----------------------|----------------------------------------------------------------------------------------------------------------|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |