RENAMEL PACK

K993659 · Cosmedent, Inc. · EBF · Jan 18, 2000 · Dental

Device Facts

• Record ID: K993659
• Device Name: RENAMEL PACK
• 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 Pack should be used for placement of posterior restorations. It can be used as the total restoration or in a layering technique to establish excellent proximal contact prior to overlay of a finishing material.

Device Story

Renamel Pack is a light-cured composite restorative material system. Used by dental professionals in clinical settings for posterior restorations. Applied as a total restoration or in a layering technique to facilitate proximal contact development before applying finishing materials. Light-curing initiates polymerization to harden the composite. Benefits include structural restoration of posterior teeth and improved contact point management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured composite restorative material system. Chemical composition details provided in confidential Appendix B. Formulated for posterior dental applications.

Indications for Use

Indicated for posterior composite restorations and contact development in posterior restorations prior to occlusal overlay of polishable materials.

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)

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a person with their arms outstretched, or a bird in flight.

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

Re : K993659 Trade Name: Renamel Pack 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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

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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 requlations.

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.fdaf.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## COSMEDENT®

## INDICATIONS FOR USE STATEMENT

510(K) Number (if known):

Kagaresa

Device Name:

Renamel Pack

Indication for Use:

Renamel Pack should be used for placement of posterior restorations. It can be used as the total restoration or in a layering technique to establish excellent proximal contact prior to overlay of a finishing material.

## Use for:

- Posterior composite restoration. 1.
- Contact development in posterior restoration prior to occlusal overlay of more 2. polishable materials.

## DESCRIPTION OF DEVICE

Renamel Pack 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.

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| | <span style="font-size: large;">Susan Rue</span> Concurrence of CDRH, Office of Device Evaluation (ODE) |
|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K993659 |

| Prescription Use | | OR | Over-the Counter Use | |
|----------------------|--|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |