(68 days)
Not Found
Not Found
No
The 510(k) summary describes a dental prosthetic (crowns and bridges) and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No.
The intended use of the device, "Porcelain Fused To Metal Crowns -Full Metal Crowns - Bridges of any span length," describes a restorative dental device, not one used for therapy or treatment of a disease or condition.
No
This device is described as "Porcelain Fused To Metal Crowns -Full Metal Crowns - Bridges of any span length," which are restorative dental devices, not diagnostic tools.
No
The provided text only describes the intended use of a physical dental device (crowns and bridges) and lacks any information about software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Porcelain Fused To Metal Crowns -Full Metal Crowns - Bridges of any span length". These are dental prosthetics used to restore teeth.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease.
- Using reagents or other materials to perform tests.
The device described is a dental restorative product, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Device Alloy: Porcelain Fused To Metal Crowns
-Full Metal Crowns
- Bridges of any span length
Product codes
EJT
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
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
0
Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or informational context.
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the central design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Holger Meinicke Director Degussa Corporation Dental Division 3950 South Clinton Avenue 07080 South Plainfield, New Jersey
OCT 1 4 1997
K972910 Re : Pors On Lite Trade Name: Regulatory Class: II Product Code: EJT Dated: July 31, 1997 Received: August 7, 1997
Dear Mr. Meinicke:
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, Druq, 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 reqistration, 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. ਸਾ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Druq 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
1
Page 2 - Mr. Meinicke
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,
Luzi Aldous
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
Page 1 of
510(k) Number (if known): K 972 910
Device Name: PORS ON LITE
Indications For Use:
Deube Alloy: Porcelain Fused To Metal Crowns
-Full Metal Crowns
- Bridges of any span length
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sig
Prescription Use_In (Per 21 CFR 801.109)
OR
Over-The-Counter Use Ms
(Optional Format 1-2-96)