(81 days)
Renamel Pack should be used for placement of posterior restorations. It can be used as the total restoration or in a layering technique to establish excellent proximal contact prior to overlay of a finishing material. Use for: Posterior composite restoration. Contact development in posterior restoration prior to occlusal overlay of more polishable materials.
Renamel Pack Composite is a system consisting of light cured composite restorative materials.
The provided text is a Food and Drug Administration (FDA) clearance letter for the Renamel Pack device (K993659). This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as typically provided in a study report.
The letter explicitly states: "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..."
This means the device was cleared based on its substantial equivalence to a predicate device already on the market, not on a new, comprehensive performance study with specific acceptance criteria that would typically be described in the context of proving a medical device meets performance standards.
Therefore, I cannot extract the requested information from the provided document. The 510(k) clearance process focuses on demonstrating equivalence to a previously cleared device, not necessarily on new clinical performance data with detailed acceptance criteria as one might find for a novel device or a PMA submission.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a person with their arms outstretched, or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 18 2000
Mr. Michael O'Malley President Cosmedent®, Inc. 401 North Michigan Avenue, Suite 2500 Chicago, Illinois 60611
Re : K993659 Trade Name: Renamel Pack Requlatory Class: II Product Code: EBF Dated: January 5, 1999 Received: January 5, 1999
Dear Mr. O'Malley:
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, 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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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 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 requlation (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.fdaf.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
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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COSMEDENT®
INDICATIONS FOR USE STATEMENT
510(K) Number (if known):
Kagaresa
Device Name:
Renamel Pack
Indication for Use:
Renamel Pack should be used for placement of posterior restorations. It can be used as the total restoration or in a layering technique to establish excellent proximal contact prior to overlay of a finishing material.
Use for:
- Posterior composite restoration. 1.
- Contact development in posterior restoration prior to occlusal overlay of more 2. polishable materials.
DESCRIPTION OF DEVICE
Renamel Pack Composite is a system consisting of light cured composite restorative materials.
A confidential chemical analysis of Renamel Pack Composite may be found in Appendix B.
(PLEASE DO NOT WRITE BELOW THIS LINE)
| Susan Rue Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K993659 |
| Prescription Use | OR | Over-the Counter Use | ||
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
§ 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.