(39 days)
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Not Found
No
The device is a soldering alloy, and the summary contains no mention of AI, ML, or related concepts.
No
The device is described as a soldering alloy for dental prosthetics and is classified as "Gold Based Alloy and Precious Metal Alloys for Clinical Use," which are materials used in the construction of devices, not therapeutic devices themselves.
No
Explanation: The device is described as a soldering alloy for dental prosthetics, which is a therapeutic/restorative material, not a device used to diagnose a medical condition.
No
The device is a physical soldering alloy, 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 for the construction and repair of dental prosthetic devices (crown and bridge). This is a dental device used in the mouth or on dental materials, not for testing samples outside the body to diagnose a condition.
- Classification: The device is classified under 21 CFR Part 872 as "Gold Based Alloy and Precious Metal Alloys for Clinical Use," which is a classification for dental devices.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, this device falls under the category of a dental device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device is a "yellow-gold" colored, soldering alloy for use in the construction and repair of crown and bridge dental prosthetic devices.
Product codes
EJT
Device Description
"Yellow-Gold" Colored, Soldering Alloy
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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vincent Benetti General Manager Aalba Dent, Incorporated · AUG 1 5 1997 400 Watt Drive Cordelia, California 94585
K972532 Re: "Yellow-Gold" Colored, Soldering Alloy Trade Name: Regulatory Class: II Product Code: EJT Dated: July 2, 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 marroo 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 chrough 312 or on introl 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 legally marketed predicate device results in a classification for your marrees 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) 594-4618. 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,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page_1_of_1_1_
K972532 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Aalba Gold Solder Device Name :_________________________________________________________________________________________________________________________________________________________________
Indications For Use: - - - ---- -
This device is a "yellow-gold" colored, soldering alloy for use in the construction and repair of crown and bridge dental prosthetic devices. According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. the classification name for this device is Gold Based Alloy and Precious Metal Alloys for Clinical Use, a Class II device.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suen Runner
(Division Sion-Off Division of Dental. and General Hospita 5 1 O(k) Number
ન્ડ Prescription Use OR (Per 21 CFR 801.109)
Over-The Counter Use_NO
(Optional Format 1-2-96)