(48 days)
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.
Not Found
The provided text is a 510(k) premarket notification approval letter for a dental light cure unit (Cute-Lite I Light Cure Unit). This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI or algorithm-driven device.
The letter is a regulatory approval for a physical medical device (a light cure unit) based on its substantial equivalence to previously marketed devices, following the provisions of the Federal Food, Drug, and Cosmetic Act. It primarily discusses regulatory classifications, general controls, and compliance requirements.
Therefore, I cannot provide details for the requested questions as the input document does not contain this type of information.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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§ 872.6070 Ultraviolet activator for polymerization.
(a)
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.(b)
Classification. Class II.