ULTRA-LITE 200E LIGHT CURE UNIT

K023545 · Rolence Ent., Inc. · EBZ · Dec 30, 2002 · Dental

Device Facts

• Record ID: K023545
• Device Name: ULTRA-LITE 200E LIGHT CURE UNIT
• Applicant: Rolence Ent., Inc.
• Product Code: EBZ · Dental
• Decision Date: Dec 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

THE ULTRA-LITE 200E IS A LIGHT CURE UNIT INTENDED FOR OF LIGHT CURED MATERIAL BY DENTAL POLYMERIZATION PROFESSIONALS.

Device Story

Ultra-Lite 200E is a dental light cure unit; used by dental professionals in clinical settings to polymerize light-cured dental materials. Device emits light energy to initiate polymerization of restorative materials. Operates as a handheld unit; provides controlled light output to ensure proper curing of dental resins. Benefits patient by facilitating efficient and effective placement of dental restorations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light cure unit for dental polymerization; handheld form factor; electrical energy source; Class II device (21 CFR 872.6070).

Indications for Use

Indicated for dental professionals to polymerize light-cured dental 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

·Mr. Sterling Chen Manager Rolence Enterprise, Incorporated 18-3, Lane 231 Pu Chung Road Chungli 320. TAIWAN R.O.C.

Re: K023545

Trade/Device Name: Ultra-Lite 200E Light Cure Unit Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: October 16, 2002 Received: October 22, 2002

Dear Mr. Chen:

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. Chen

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 (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). 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/cdrb/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timo Jlatowski 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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510(k) Number (if known)

ULTRA-LITE 200E LIGHT CURE UNIT Device Name:

Indications For Use:

THE ULTRA-LITE 200E IS A LIGHT CURE UNIT INTENDED FOR OF LIGHT CURED MATERIAL BY DENTAL POLYMERIZATION PROFESSIONALS.

Robert Skitz DDS for Dr. Susan Renner

nesthesiolog eneral Hospital. Infection Control, Denta

510(k) Number: K023545

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)