(36 days)
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No
The 510(k) summary describes a dental alloy, which is a material used in restorations, and there is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device is a dental alloy used for fabricating crowns, bridges, inlays, and onlays, which are restorative materials, not devices intended for therapy.
No
Explanation: The device is described as a "HIGH NOBLE DENTAL ALLOY FOR THE FABRICATION OF SINGLE CROWNS, BRIDGES, INLAYS AND ONLAYS." This indicates it is a material used for restorative dental procedures, not a tool for diagnosing medical conditions.
No
The intended use describes a dental alloy for fabricating physical dental restorations, which is a hardware 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 "HIGH NOBLE DENTAL ALLOY FOR THE FABRICATION OF SINGLE CROWNS, BRIDGES, INLAYS AND ONLAYS." This describes a material used to create dental prosthetics, which are implanted or placed in the body.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, this device falls under the category of a dental material used for restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
HIGH NOBLE DENTAL ALLOY FOR THE FABRICATION OF SINGLE CROWNS, BRIDGES, INLAYS AND ONLAYS.
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
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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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§ 872.3060 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
OCT 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Prometal Technologies C/O Ms. Donna Marie Hartnett, Esq. 67 Main Street Silver Creek, New York 14136
Re: K052463
Trade/Device Name: Prometal HN86 Regulation Number: 21 CFR 872.3060 Regulation Name: Noble Metal Alloy Regulatory Class: II Product Code: EJT Dated: August 31, 2005 Received: September 08, 2005
Dear Ms. Hartnett:
We have reviewed your Section 510(k) premarket notification of intent to market the device w one reviewed your betermined the device is substantially equivalent (for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass sured in all encreated of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic nate boon receinds not require approval of a premarket approval application (PMA). 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 connolor provision, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device to such additional controls. Existing major regulations affecting your device can be fray of subject to sail Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 -- Donna Marie Hartnett, Esq
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, PhD
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1052463 510(k) Number (if known): _
Device Name: PROMETAL HN86
Indications for Use:
HIGH NOBLE DENTAL ALLOY FOR THE FABRICATION OF SINGLE CROWNS, BRIDGES, INLAYS AND ONLAYS.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susen Runn
(Division Sign-Off) (ENISION Of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_