EXCELLITE LIGHT CURE UNIT

K020884 · Rolence Ent., Inc. · EBZ · Jun 12, 2002 · Dental

Device Facts

• Record ID: K020884
• Device Name: EXCELLITE LIGHT CURE UNIT
• Applicant: Rolence Ent., Inc.
• Product Code: EBZ · Dental
• Decision Date: Jun 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2

Intended Use

THE EXCELLITE IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS .

Device Story

Excellite is a light cure unit used by dental professionals in clinical settings. Device emits light to polymerize light-cured dental materials. Operation involves manual activation by the clinician to initiate the curing process. Output is a light source directed at dental restorative materials to facilitate hardening. Benefits include efficient curing of dental composites and adhesives.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Ultraviolet/visible light activator for polymerization. Form factor is a handheld or benchtop dental light cure unit. Energy source is electrical power. Device functions as a light source for dental material curing.

Indications for Use

Indicated for polymerization of light-cured dental materials by dental professionals.

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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined strands, representing the department's focus on health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

JUN 12 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sterling Cheng Manager Rolence Enterprise, Incorporated 18-3 Lane 231 Pu Chung Road Chungli, TAIWAN

Re: K020884

Trade/Device Name: Excellite Ligt Cure Unit Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: March 14, 2002 Received: March 18, 2002

Dear Mr. Cheng:

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 of the Act or any Federal statutes and regulations administered by other Federal agencies.

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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 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy 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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KO2 510(k) Number (if known):___

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

THE EXCELLITE IS A LIGHT CURE UNIT INTENDED FOR POLYMERIZATION OF LIGHT CURED MATERIAL BY DENTAL PROFESSIONALS .

Tack hung

(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 | K 020884 |
|---------------|----------|
|---------------|----------|

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

..

(Optional Format 1-2-96)