(42 days)
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The intended use describes a brazing process, which is a manufacturing technique, not a diagnostic or therapeutic application where AI/ML is commonly used.
No
The device is used for brazing dental alloys, which is a manufacturing process and not directly involved in treating or diagnosing diseases/conditions in patients.
No
The device is described as being "Used for brazing dental alloys prior to porcelain application," which is a manufacturing or fabrication process, not a diagnostic one.
No
The provided text describes a device used for brazing dental alloys, which is a physical process involving hardware. There is no mention of software as the primary or sole component.
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 materials outside of the human body, specifically dental alloys.
- Lack of Biological Sample Interaction: IVDs are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not interact with any biological samples.
- No Mention of Diagnosis or Health Information: The intended use does not mention providing any diagnostic information or information about a patient's health status.
The device described is a tool used in a dental laboratory or clinical setting for a technical process related to dental prosthetics, not for diagnosing or monitoring a medical condition.
N/A
Intended Use / Indications for Use
Used for brazing dental alloys prior to porcelain application.
Product codes
EJT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 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 an abstract symbol that resembles three human profiles facing right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2002
Mr. Anderjeet Gulati Quality Assurance Manager Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K022969
Trade/Device Name: Universal Ceramic Solder Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: August 30, 2002 Received: September 06, 2002
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. Anderjeet 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
Title: A. Uluturk
Timo Ulatowski Directo Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | Not yet assigned | K0229694 |
|---|---|---|
| --------------------------- | ------------------ | ---------- |
| Device Name:
Universal Ceramic Solder
| been the same management somewood in the first to trinks to treating and man personal come of can all results of any and of the results of the results of the results of the r |
|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Indications For Use:
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 ✔ (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96) Warr
OR
(Division Sign-Off) (Division Oigh Sign Sthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K003416