SAVEDENT BLUE

K042196 · Denfotex Light Systems, Ltd. · EBZ · Nov 1, 2004 · Dental

Device Facts

• Record ID: K042196
• Device Name: SAVEDENT BLUE
• Applicant: Denfotex Light Systems, Ltd.
• Product Code: EBZ · Dental
• Decision Date: Nov 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

Light source for the activation of light cured resin polymers and glass ionomer materials used in dentistry as pit and fissure sealants, restorative materials, and bonding materials.

Device Story

SAVEDENT BLUE is a lightweight, handheld LED-based dental curing light. It is operated by dental professionals in a clinical setting to polymerize resin or glass ionomer-based dental materials used for restorative, sealing, or cementing procedures. The device delivers up to 1000mW/cm2 of light energy for user-selectable durations between 10 and 40 seconds. By providing the necessary light intensity and wavelength, the device initiates the curing process, allowing the clinician to harden dental materials in situ. This facilitates efficient restorative and bonding workflows, ultimately benefiting the patient by ensuring the structural integrity and proper setting of dental restorations.

Clinical Evidence

Bench testing only. Comparative performance testing demonstrated that the SAVEDENT BLUE provides the same or better cure depth for a given exposure time compared to the predicate device.

Technological Characteristics

Handheld LED-based light curing unit. Delivers up to 1000mW/cm2. Operates at specific wavelengths for polymerizing dental resins and glass ionomers. User-selectable exposure times (10-40 seconds).

Indications for Use

Indicated for use by dental professionals as a light source to polymerize, cure, harden, or set resin or glass ionomer-based dental materials, including pit and fissure sealants, restorative materials, and bonding materials.

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.

Predicate Devices

• Elipar™ Freelight (K011154)

Submission Summary (Full Text)

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Denfotex Light Systems Ltd

Image /page/0/Picture/1 description: The image is a black and white circular logo with the word "Denfotex" written in white letters across the center. The background of the circle is black. The text is in a simple, sans-serif font and is horizontally centered within the circle.

NOV - 1 2004

## Kouzing

Unit 15, Belleknowes Ind.Est., Inverkeithing, Fife KY11 1HZ Tel. [phone] Fax [phone]

## 510(k) SUMMARY

Submitted by Dr John Colles, Innovations Director Contact Dr John Colles. Telephone as above or Mobile no. 07786518919 Date: 15-04-04

## Name of Device.

| Proprietary Name: | SAVEDENTTM BLUE |
|----------------------|------------------------------------------|
| Classification Name: | Ultraviolet activator for polymerisation |
| Common Name: | Light Curing Unit. |

Classification ... ... ............................. Ultraviolet activator under 872.3260 (class 2) Dental panel, product code EBZ.

Predicate Device.

Elipar™ Freelight from 3M ESPE ......... K011154 (Product Code: EBZ).

## Description for the Premarket notification.

SAVEDENT The BLUE is a LED based curing light intended to polymerise and therefore cure, harden or set resin or glass ionomer based dental materials used for restorative, sealing or cementing procedures. It is a lightweight handheld unit delivering up to 1000mW/cm2 for set times between 10 and 40 seconds. It has the same intended purpose, uses the same technology as and offers the same significant output parameters (power density and wavelength) as the predicate device and is therefore substantially equivalent to it.

Comparative tests have demonstrated that SAVEDENTIAN BLUE provides the same or better performance in terms of cure depth for a given exposure time as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2004

Denfotex Light Systems Limited C/O Mr. William J. Sammons Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, North Carolina 27709-3995

Re: K042196

Trade/Device Name: SAVEDENT BLUE Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: October 19, 2004 Received: October 19, 2004

Dear Mr. Sammons:

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 – Mr. Sammons

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 modifine and regulations and regulations administered by other Federal agencies. or mo receir any a vith 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 and ifouns (2) - set forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquicable, 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) I mis letter wification. The FDA finding of substantial equivalence of your device to a promarket notificated 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), n you accures of 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 from the may overn 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,

Carls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

K042196 510(k) Number (if known):

Device Name: _SAVEDENT BLUE

Indications For Use:

Light source for the activation of light cured resin polymers and glass ionomer materials used in dentistry as pit and fissure sealants, restorative materials, and bonding materials.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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 Anesthesiology, General Hospital. Infection Control, De

510(k) Number: K042196