(48 days)
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No
The summary describes a traditional dental porcelain material and its intended use in fabricating dental prostheses, with no mention of AI or ML technology.
No
The device, Antagon Porcelain, is used to create components of a dental prosthesis, which is then placed in the patient's mouth by a dentist. It is a material used in the fabrication process, not a device directly used for therapy or treatment on a patient.
No
The device is used to fabricate dental prostheses, specifically to fashion and bake porcelain veneers onto dental alloy substrates. This is a manufacturing process, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions or diseases.
No
The device description and intended use clearly describe a physical material (porcelain) used in the fabrication of dental prostheses, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of Antagon Porcelain is to fashion and bake porcelain veneers onto dental alloy substrates to create dental prostheses. This process is about fabricating a device that will be placed in the patient's mouth, not about analyzing a biological sample from the patient.
- The process described is a manufacturing/fabrication process. It involves working with materials (porcelain and dental alloy) to create a finished product (a dental prosthesis). This is distinct from the diagnostic process of analyzing a sample to gain information about a patient's health.
Therefore, Antagon Porcelain, as described, falls under the category of a dental material used in the fabrication of a medical device (a dental prosthesis), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis.
Antagon Porcelain is recommended for use with any normalfusing-temperature dental ceramic alloy.
After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.
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
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Intended User / Care Setting
dental lab technician, attending dentist
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 1998
Mr. Michael H. Everngam ·President European Dental Imports, Incorporated 49 Emerson Road P.O. Box 799 Durham, New Hampshire 03824-0799
K982129 Re : Trade Name: Antagon Porcelain Regulatory Class: II Product Code: EIH Dated: June 17, 1998 Received: June 17, 1998
Dear Mr. Everngam:
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 qeneral 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. ਜੋ 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 obligation you might have under sections 531
1
Page 2 - Mr. Everngam
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"(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,
S. Autman for
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) Premarket Notification for Antagon Dental Porcelain. Submitted by european dental imports, inc., Reg#1218814
INDICATIONS FOR USE:
510(K) Number: K982129
Device Name: Antagon Porcelain
Indications for Use:
Used by a dental lab technician, under the direction of an attending dentist, to fashion and bake porcelain veneers onto dental alloy substrates so as to create the porcelainfused-to-metal elements of a fixed or removable dental prosthesis.
Antagon Porcelain is recommended for use with any normalfusing-temperature dental ceramic alloy.
After fabrication and finishing, the completed prosthesis is approved and placed in the patient's mouth by the dentist.
(Please do not write below this line) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation
Prescription Use (Per 21 CFR 801.109)
Over the Counter Use
Susan Runns
OR
Division of Dental. Infection Control.