(46 days)
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K/DEN number is Not Found in the text.
No
The summary describes porcelain powders for dental restorations and contains no mention of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.
No.
The product is described as porcelain powders for dental restorations, which are materials used in a therapeutic context but are not themselves a therapeutic device that performs a therapeutic action on a patient.
No
Explanation: The device is described as porcelain powders used in a pressable ceramic system for dental restorations. It does not mention any function related to diagnosing diseases or conditions.
No
The device description clearly states it is "porcelain powders used in our pressable ceramic system," indicating a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental restorations (crowns and bridges) using porcelain powders. This is a manufacturing process for a medical device, not a diagnostic test performed on a biological sample.
- Device Description: The device is described as porcelain powders used in a pressable ceramic system. This aligns with materials used in dental prosthetics, not diagnostic reagents or instruments.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Eris Layering materials are components used in the fabrication of dental devices, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
EIH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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:
1
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
2
| 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