(60 days)
Not Found
Not Found
No
The summary describes a casting alloy, a material used in dental prosthetics, with no mention of software, algorithms, or any computational processing that would involve AI or ML.
No
The device is described as a casting alloy for prosthetic devices, which are replacements for body parts, not devices used for therapy or treatment of diseases.
No
Explanation: The device is described as a "casting alloy for use in full coverage and onlay prosthetic devices," which are restorative materials, not tools for diagnosing medical conditions.
No
The device is described as a "casting alloy," which is a physical material used in dental prosthetics, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "full coverage and onlay prosthetic devices," which are dental restorations used in the mouth of a patient.
- Device Description: It's a "casting alloy," a material used to create these prosthetic devices.
- 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.
- Being used in a laboratory setting for testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This casting alloy is a material used to fabricate a medical device that is placed in the body, not used to test samples from the body.
N/A
Intended Use / Indications for Use
This device is a "white" colored, casting alloy for use in This device is a wires on coverage onlay prosthetin According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. devices. the classification name for this device is Base Metal Alloy, a Class II device. FOR USE WITTH DENTAL PORCELAIN NOT ( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDI:D. )
Product codes
EJS
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 Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 1997
Mr. Vincent Benetti General Manaqer Aalba Dent Incorporated 400 Watt Drive 94585 Cordelia, California
Re: K972534 "White" Colored, Casting Alloy Trade Name: Regulatory Class: II Product Code: EJS Dated: June 30, 1997 Received: July 7, 1997
Dear Mr. Benetti:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਹੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Fractice 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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. Benetti ----
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 leqally 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.qov/cdrh/dsmamain.html".
Sincerely yours,
hv A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Page_1________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): __ K972534_
Alfalloy__ Device Name : .. _
Indications for Use: --
This device is a "white" colored, casting alloy for use in This device 18 a wires on coverage onlay prosthetin According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. devices. the classification name for this device is Base Metal Alloy, a Cla:s II device.
FOR USE WITTH DENTAL PORCELAIN NOT ( PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDI:D. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
(Division Sign-Off) Division of Dental, Infection Co and General Hosp 510(k) Number
Prescription Use Y (Per 21 CFR 101.109) OR
Over-The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)