(86 days)
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No
The summary describes a dental solder used for brazing, which is a material and process, not a software-driven device. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a solder used for brazing dental alloys, which is a manufacturing or repair process for dental prosthetics, not directly applied to a patient for treatment or diagnosis.
No
Explanation: The device is described as "High Gold Palladium Free Ceramic Solder" used for brazing dental alloys, which is a manufacturing or repair process, not a diagnostic one.
No
The device description clearly indicates a physical material ("High Gold Palladium Free Ceramic Solder") used for brazing, which is a hardware component and process, 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 "Used for brazing dental alloys prior to porcelain application." This describes a process performed on dental materials outside of the human body, specifically for the creation of dental prosthetics.
- Device Description: The device is a "High Gold Palladium Free Ceramic Solder." This is a material used in a manufacturing or fabrication process.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing specimens derived from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Being used in a laboratory or clinical setting for diagnostic purposes.
IVDs are specifically designed to be used in vitro (outside the living organism) to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This dental solder does not fit that description.
N/A
Intended Use / Indications for Use
Used for brazing dental alloys prior to porcelain application.
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
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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 is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, with three stylized lines representing the wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 2001
Mr. Anderjeet Gulati Quality Assurance Manager Ivoclar USA, Incorporated 175 Pineview Drive Amherst. New York 14150
Re: K012877
Trade/Device Name: High Gold Palladium Free Ceramic Solder Regulation Number: 872.3060 Regulation Name: Alloy For Procelain Fused To Metal Regulatory Class: II Product Code: EJT Dated: August 22, 2001 Received: August 27, 2001
Dear Mr. Gulati:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do 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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.
1
Page 2 - Mr. Gulati
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 (QS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/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
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| 510(k) Number (if known): | Not yet assigned K012877 |
|---|---|
| --------------------------- | -------------------------- |
High Gold Palladium Free Ceramic Solder Device Name:
Indications For Use:
: 上一篇: :
Used for brazing dental alloys prior to porcelain application.
、
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X (Per 21 CFR 801.109) |
|---|---|
| ------------------ | ------------------------ |
OR
| Over-The-Counter Use | _ (Optional Format 1-2-96) |
|---|---|
| ---------------------- | ---------------------------- |
| Division Sign-Off | |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number |