(54 days)
Not Found
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or performance studies typically associated with AI/ML-powered devices. The intended use is purely for fabrication, which is a mechanical process.
No
The device is used for fabrication of dental prosthetics, which are restorative rather than therapeutic.
No
The "Intended Use / Indications for Use" describes fabrication tasks (dental crowns, bridges, inlays, and low-fusing porcelain-fused-to-metal applications), which are manufacturing activities, not diagnostic ones. Diagnostic devices are used to identify or determine the nature of a disease or condition.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Fabrication of Dental Crowns, Bridges, Inlays and Low-fusing Porcelain-fused-to-metal Applications." This describes a device used in the manufacturing or creation of dental prosthetics, which are medical devices used in the body, not for testing samples from the body.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
IVDs are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The intended use described here falls outside of this definition.
Therefore, based solely on the provided text, this device appears to be a dental manufacturing device, not an IVD.
N/A
Intended Use / Indications for Use
Fabrication of Dental Crowns, Bridges, Inlays and Low-fusing Porcelain-fused-to-metal Applications.
Product codes
EJS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure with outstretched arms, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 1999
Mr. Kenneth A. Putney Vice President, General Manager Official Correspondent Metalor Dental USA Corporation 255 John L. Dietsch Boulevard, P.O. Box 255 North Attleborough, Massachusetts 02761-0255
Re: K993506 Pagalinor 4 Trade Name: Requlatory Class: II Product Code: EJS October 11, 1999 Dated: Received: October 15, 1999
Dear Mr. Putney:
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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ಡ 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 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
1
Page 2 - Mr. Putney
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 requlations.
This letter will allow you to beqin 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 vour 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 yitro 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
2
| 510(k) Number (if known): | K993506 |
|---|---|
| Device Name: | Pagalinor 4 |
Page ofIndications For Use:
Device Name: ___
Fabrication of Dental Crowns, Bridges, Inlays and Low-fusing Porcelain-fused-to-metal Applications.
(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 (Optional Format 1-2-96)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, Division of Dental, Infection Control
and General Hospital Dexices
510(k) Number ---------------------------------------------------------------------------------------------510(k) Number _
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