Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT

K980793 · Rolence Enterprise Co. , Ltd. · EBF · May 15, 1998 · Dental

Device Facts

• Record ID: K980793
• Device Name: Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT
• Applicant: Rolence Enterprise Co. , Ltd.
• Product Code: EBF · Dental
• Decision Date: May 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURE 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

Q-Luxpro V/Q-Luxpro II is a dental light cure unit; emits light in 400-500 nm range; used by dental professionals to polymerize light-activated restorative materials (composites, sealants, bonding agents). Device facilitates restoration of tooth function and aesthetics. Operated in clinical dental settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light cure unit; output wavelength range 400-500 nm; intended for polymerization of dental restorative materials. No specific materials, software, or connectivity details provided.

Indications for Use

Indicated for polymerization of light-cure dental restorative materials, including composites, pit and fissure sealants, bonding agents, and adhesion primers, used to restore tooth function and appearance in patients.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like symbol with three stylized lines forming the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 1998

Mr. Sterling Chenq ·Manaqer Rolence Enterprise Co., Ltd. 226 Kong-Shieh-Sir Village Chungli, TAIWAN R.O.C.

Re : K980793 Trade Name: Q-Luxpro V/Q-Luxpro II Light Cure Unit Regulatory Class: II Product Code: EBE February 25, Dated: 1998 Received: March 2, 1998

Dear Mr. Chenq:

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 leqally 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Cheng

through 542 of the Act for devices under the Electronic enrough 312 or on Control provisions, or other Federal laws or requlations.

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" (21CFR 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/dsma/dsmamajn.html".

Sincerely yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) NUMBER (IF KNOWN) : --------------------------------------------------------------------------------------------------------------------------------------------------

DEVICE NAME:

Q-LUXpro V/Q=LUXpro II LIGHT CURE UNIT INDICATIONS FOR USE:

TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURE 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)

OR

Over-The-Counter-Use
(Optional Format 1-2-96)

(Divisio Division of Donnel, Infortun, Dontro and General treati 510(k) Number