ICE

K012528 · Southern Dental Industries, Ltd. · EBF · Oct 22, 2001 · Dental

Device Facts

• Record ID: K012528
• Device Name: ICE
• Applicant: Southern Dental Industries, Ltd.
• Product Code: EBF · Dental
• Decision Date: Oct 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Microfil hybrid restorative for all cavity classes, veneers and diastema closures.

Device Story

ICE is a microfil hybrid dental restorative material used by dentists in clinical settings. It is applied to teeth to restore structure in all cavity classes, veneers, and diastema closures. The material functions as a restorative composite, providing structural support and aesthetic correction for dental defects. It is intended for prescription use by dental professionals.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory classification and intended use.

Technological Characteristics

Microfil hybrid dental composite restorative material. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for use as a microfil hybrid restorative material for all cavity classes, veneers, and diastema closures in patients requiring dental 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)

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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 stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 22 2001

Southern Dental Industries, Limited C/O Ms. Samantha J. Cheetham Official Correspondent Southern Dental Industries, Incorporated 729 N. Route 83, Suite 315 Bensenville, Illinois 60106

Re: K012528

Trade/Device Name: ICE Regulation Number: 872.3690 Regulation Name: Dental Composite-Anterior Restorative Regulatory Class: II Product Code: EBF Dated: July 30, 2001 Received: August 6, 2001

Dear Ms. Cheetham:

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 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.

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

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Page 2 - Ms. Cheetham

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

[signature]

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

Enclosure

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Page 1 of 1

510(k) Number (if known):

Device Name:

ICE

Indications For Use:

Microfil hybrid restorative for all cavity classes, veneers and diastema closures.

(Please do not Write Below This Line - Continue on another Page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|----------------------------------------|--------|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K92528 |

| Prescription Use: | <div>(Per 21 CFR 801.109)</div> | OR | Over-The-Counter Use: |
|-------------------|---------------------------------|----|--------------------------|
| | | | (Optional Format 1-2-96) |