CUTE-LITE I LIGHT CURE UNIT

K991863 · Rolence Enterprise Co. , Ltd. · EBZ · Jul 19, 1999 · Dental

Device Facts

• Record ID: K991863
• Device Name: CUTE-LITE I LIGHT CURE UNIT
• Applicant: Rolence Enterprise Co. , Ltd.
• Product Code: EBZ · Dental
• Decision Date: Jul 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURED DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.

Device Story

Cute-Lite I Light Cure Unit is a dental device designed to emit light in the 400-500 nm range. It is used by dental professionals in a clinical setting to polymerize light-cured dental restorative materials, such as composites, sealants, and bonding agents. By providing the necessary light energy, the device facilitates the hardening of these materials, thereby restoring the function and appearance of a patient's teeth. The device operates as a standalone light source for dental procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light cure unit emitting 400-500 nm wavelength; standalone device; intended for dental restorative material polymerization.

Indications for Use

Indicated for patients requiring dental restoration using light-cured materials, including composites, pit and fissure sealants, bonding agents, and adhesion primers.

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

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 19 1999

Mr. Sterling Chenq Manaqer Rolence Enterprise Company, LTD. 18-3 Lane 231 PU Chung Road Chungli, Taiwan R.O.C.

Re : K991863 Cute-Lite I Light Cure Unit Trade Name: Requlatory Class: II Product Code: EBZ May 27, 1999 Dated: Received: June 1, 1999

Dear Mr. Cheng:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. मे substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.

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Page 2 - Mr. Cheng

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
K. Vitale

Timothy A. Ulatowski 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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of Page

K991863

510(k) NUMBER (IF KNOWN) : CUTE-LITE I LIGHT CURE UNIT DEVICE NAME:

INDICATIONS FOR USE:

TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURED DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) \$\underline{\hspace{1cm}}\$

OR

Susan Russo

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number
K991863

Over-The-Counter-Use
(Optional Format 1-

F/A/CDRH/ODE/DN

Jul 18 9 52 AM

RECEIVE

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