(60 days)
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No
The summary describes a dental soldering alloy, a material used in prosthetics, with no mention of software, data processing, or any technology related to AI or ML.
No
The device is a soldering alloy used for construction and repair of dental prosthetic devices, which is not a therapeutic function. Therapeutic devices are typically used for treating or curing diseases or conditions, or for restoring function.
No
The device is a soldering alloy used for dental prosthetics, which is a restorative material, not a tool for diagnosis.
No
The device is described as a "soldering (welding) alloy" and a "Base Metal Alloy," which are physical materials, 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 mechanical/structural application, not a diagnostic test performed on biological samples.
- Device Description: It's a soldering alloy, a material used for joining metals.
- Classification: It's classified as a "Base Metal Alloy" under 21 CFR Part 872, which is a regulation for dental devices, not IVDs.
- 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.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, this device falls under the category of a dental prosthetic material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This device is a "white" colored, soldering (welding) 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 Base Metal Alloy, a Class II device.
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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 consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The graphic is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 1997
Mr. Vincent Benetti General Manager Aalba Dent Incorporated ---400 Watt Drive Cordelia, California 94585
Re : K972533 "White" Colored, Soldering (Welding) Alloy Trade Name: Requlatory Class: II Product Code: EJS Dated: July 2, 1997 Received: July 7, 1997
~ ー
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. ಗಳ 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 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 cirough 542 or the new for roundsions, 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 " described in your 510\x) prematice necessor device to a legally Finding of subscanced cqazard.org of classification for your marketed predicate actres your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire bpcorred additionally 809.10 for in regulation (ir er ex vices), please contact the Office of Victo dragnobere at (301) 594-4618. Additionally, for questions on Compriance at (301) deertising of your device, please contact the promocion and advertibing of your 4639. Also, please note the Office of compriance as (oranding by reference to the regulation encreaca, "Iremand 97) Other general premarket notification of the one of the Act may be Information on your responsibiliation of Small Manufacturers Assistance obcarned from the brying (800) 638-2041 or (301) 443-6597 or at at its coll-free number (600)- 050 Ha.gov/cdrh/dsmamain.html".
Sincerely yours,
Ki Alatrest
y A. Ulatowski Timo 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):_____________________________________________________________________________________________________________________________________________________
Vera Solder__ Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
This device is a "white" colored, soldering (welding) 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 Base Metal Alloy, 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)
Susan Runner
(Division Sign-Off) Division of Denis and General Hospi: : :
510(k) Number KA22533
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)