(42 days)
Used for brazing dental alloys prior to porcelain application.
Not Found
This is an FDA 510(k) clearance letter for a dental device (Universal Ceramic Solder) from 2002. It refers to the device's substantial equivalence to a legally marketed predicate device. This type of document, particularly from this era, typically does not contain detailed primary study data, acceptance criteria, or ground truth methodologies that are common in more recent AI/ML device submissions.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be provided:
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A table of acceptance criteria and the reported device performance:
- Cannot be provided. This document does not detail specific acceptance criteria or performance metrics for the Universal Ceramic Solder. The clearance is based on "substantial equivalence" to a predicate device, which implies the new device performs similarly without necessarily requiring extensive new performance data to be reported in the 510(k) summary (especially for devices in 2002).
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. The document does not mention any specific test sets, sample sizes, or data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. No information about ground truth establishment or experts is present.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No adjudication method is mentioned.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This is a clearance for a physical dental solder, not an AI-assisted diagnostic device. MRMC studies and AI assistance are not relevant to this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. No information about ground truth is present. For a traditional material like a ceramic solder, performance would typically be assessed by material properties (e.g., bond strength, biocompatibility) rather than ground truth in the sense of diagnostic accuracy.
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The sample size for the training set:
- Cannot be provided. This is not an AI/ML device requiring a training set.
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How the ground truth for the training set was established:
- Cannot be provided. Not applicable.
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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.
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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
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| 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 |
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| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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
§ 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.