(74 days)
TO PRODUCE LIGHT FOR FORME MATERIAL SUCH AS LIGHT CURE COMPOSITES, CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES , CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMESSITES , CURE DENTAL SESTORATIVE BONDING AGENTS, ADENTS, ADHESTON PRIMERS ETC. PIT AND FISSURE SEALANTS, BONDING AGENTS, FECTION AND APPEARANCE WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.
Not Found
The provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental light cure unit. It does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The letter primarily informs the manufacturer that their device, the CU-100A Light Cure Unit, has been determined substantially equivalent to legally marketed predicate devices.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth from the provided text.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles facing right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the emblem. The emblem is a symbol representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 1998
Mr. Sterling Cheng ·Manager Rolence Enterprise Co., Ltd. 226 Kong-Shieh-Sir Village Chungli, TAIWAN R.O.C.
Re : K980792 CU-100A Light Cure Unit Trade Name: Regulatory Class: II Product Code: EBF February 25, 1998 Dated: March 2, 1998 Received:
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 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Reqister. 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 chrough 542 or cho noversions, 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 markets production 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"(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 (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.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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Image /page/2/Picture/1 description: The image shows two metal clips, possibly paper clips or similar fasteners. The top clip is oriented diagonally with its open end facing upwards and to the left. The bottom clip is positioned below the first, also diagonally, with its looped end on the left and a bent end on the right. Both clips appear to be made of thin metal wire.
510(k) NUMBER (IF KNOWN): ____________________________________________________________________________________________________________________________________________________
DEVICE NAME:
CU-100A LIGHT-CURE UNIT
INDICATIONS FOR USE:
TO PRODUCE LIGHT FOR FORME MATERIAL SUCH AS LIGHT CURE COMPOSITES, CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES ,
CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMESSITES , CURE DENTAL SESTORATIVE BONDING AGENTS, ADENTS, ADHESTON PRIMERS ETC. PIT AND FISSURE SEALANTS, BONDING AGENTS, FECTION AND APPEARANCE
WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANCTHER 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)
Susa Suno
(Division Sign-Off) Division of Dealel, Infection Control, and General Facepital Devices પ્રસ્પત 510021 Mamber
§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.