RADII

K030568 · Southern Dental Industries, Inc. · EBZ · Apr 24, 2003 · Dental

Device Facts

• Record ID: K030568
• Device Name: RADII
• Applicant: Southern Dental Industries, Inc.
• Product Code: EBZ · Dental
• Decision Date: Apr 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Polymerization of light curing dental materials with photo initiator for the wavelength range 440 – 480 nm. Suitable for light curing composite restorative materials, anterior composites, posterior composites, bonding agents, pit and fissure sealants, orthodontic adhesive and flowable composites.

Device Story

Radii is a dental curing light used by dentists to polymerize light-activated restorative materials. Device emits blue light in 440–480 nm range to trigger photo-initiators in dental composites, bonding agents, sealants, and orthodontic adhesives. Operated by dental professionals in clinical settings to harden restorative materials during dental procedures. Benefits include efficient, rapid curing of dental materials, facilitating restorative and orthodontic treatments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultraviolet activator for polymerization; wavelength range 440–480 nm; handheld form factor; Class II device per 21 CFR 872.6070.

Indications for Use

Indicated for the polymerization of light-curing dental materials (composites, bonding agents, sealants, orthodontic adhesives) containing photo-initiators sensitive to the 440–480 nm wavelength range.

Regulatory Classification

Identification

An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

APR 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Samantha J. Cheetham Official Correspondent Southern Dental Industries, Incorporated 729 North Route 83, Suite 315 Bensenville, Illinois 60106

Re: K030568

Trade/Device Name: Radii Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ Dated: February 20, 2003 Received: February 24, 2003

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.

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Page 2 – Ms. Samantha J. Cheetham

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 (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.

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]. 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) you may obtain. 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,

Susan Runres

Susan Runner, DDS, MA Interim 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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510(k) Number (if known):

Device Name:

Indications For Use:

Radii

Ko30568

Polymerization of light curing dental materials with photo initiator for the wavelength range 440 – 480 nm.

Suitable for light curing composite restorative materials, anterior composites, posterior composites, bonding agents, pit and fissure sealants, orthodontic adhesive and flowable composites.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | <b>X</b> | OR | Over-The-Counter Use: | |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|----|-----------------------|--------------------------|
| (Per 21 CFR 801.109) | | | | (Optional Format 1-2-96) |
| | <div align="center">Kei Muby <span style="font-size: smaller;">for MSM</span></div> | | | |
| | (Division Sign-Off) | | | |
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | | | | |
| 510(k) Number: | K030568 | | | |