(46 days)
Eris Layering materials are porcelain powders used in our pressable ceramic system, Eris Layering materials are personal free single unit, and multiple unit bonded crown and bridge restorations.
Eris Layering materials are porcelain powders used in our pressable ceramic system
I am sorry, but the provided text is a standard FDA 510(k) clearance letter for a dental material (Eris Layering Materials). It establishes substantial equivalence to a predicate device and permits marketing.
The document does not contain any information about:
- Acceptance criteria for the device's performance.
- Any study that proves the device meets specific acceptance criteria.
- Device performance data.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established.
Therefore, I cannot provide the requested information based on the input text.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. The eagle is surrounded by a circular border containing the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2001
Ms. Donna M. Hartnett Assistant Corporate Counsel Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228
Re : K012174 Trade/Device Name: Eris® Laying Material 21 CFR 872.6660 Requlation Number: Regulatory Class: II Product Code: EIH Dated: July 10, 2001 Received: July 12, 2001
Dear Ms. Hartnett:
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 legally 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 Regulations, 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Ms. Hartnett
his response to your premarket notification submission does not affect any obligation you might have under sections 531 not arrough 542 of the Act for devices under the Electronic chrough 512 Or chorol 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 marress 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) 594-4613. 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 requlation 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 International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmama/in.html.
Sincerely,
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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| 510(k) Number (if known): | to be assigned (K012174) |
|---|---|
| --------------------------- | -------------------------- |
Device Name:
Eris Layering Materials
Indications For Use:
Eris Layering materials are porcelain powders used in our pressable ceramic system, Ens Eayening matonals are personal free single unit, and multiple unit bonded crown and bridge restorations.
(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_
Merald W
(Division Sign-Off)
Division
(Optional Format 1-2-96)
(Contision of Dental, Infection Control,
Division of Dental, Infection Control, and General Hospital, Infection of
510(k) Number K012174
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.