(54 days)
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Not Found
No
The summary describes a machinable ceramic material for dental restorations and contains no mention of AI or ML technology.
No
The device is described as a machinable ceramic for use in the construction of ceramic Fixed Restorations, which are materials used in dental procedures, not therapeutic devices themselves.
No
The product is described as a machinable ceramic for constructing fixed restorations, which is a material used in treatment, not for diagnosing conditions.
No
The intended use describes a "machinable ceramic," which is a physical material, not software. The summary provides no information about any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a machinable ceramic for use in the construction of ceramic Fixed Restorations." This describes a material used to build a physical dental restoration, not a test performed on a biological sample to diagnose a condition.
- Lack of IVD Characteristics: The description lacks any mention of:
- Testing biological samples (blood, urine, tissue, etc.)
- Diagnosing, monitoring, or screening for diseases or conditions
- Using reagents or assays
- Analyzing biological markers
The device is a material used in a manufacturing process (constructing dental restorations), which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The indicated usage for this product is as a machinable ceramic for use in the construction of ceramic Fixed 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
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Intended User / Care Setting
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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.
0
Image /page/0/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 1999
Mr. Ron Fishell CAD CAM VENTURES 3301 Conflans Road, Suite 104 Irving, Texas 75061
K991844 Re : Trade Name: Pro-Glass Regulatory Class: II EIH Product Code: Dated: May 26, 1999 May 28, 1999 Received:
Dear Mr. Fishell:
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 The general controls provisions of the Act 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 requlations 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 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 regulations.
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Page 2 - Mr. Fishell
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.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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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Page 4
510(k) Number (if known): K991844
Device Name: Pro Glass
Indications For Use:
11.00 .
The indicated usage for this product is as a machinable `ceramic for use in the construction of ceramic Fixed Restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-the-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| Suoar Rinas (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
|---|---|
| 510(k) Number | 10991844 |