(61 days)
EURO 50 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Crowns, Short span bridges, Long span bridges and can be used for Telescopic and milling work. EURO 50 can be veneered with suitable dental ceramics as well as with dentalcomposites.
EURO 50 is a gold-palladium ceramic alloy with high contents of noble metals (78,2%) intended for dental technicians to fabricate dental restorations. It has an indication which ranges from single crowns up to long span bridges with two or more pontics. It is free of copper and therefore suitable for telescopic and milling work. EURO 50 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. EURO 50 can be veneered with suitable dental ceramics and with dental composites.
This document is a 510(k) summary for a dental alloy, not a medical device that uses AI or requires performance studies with complex acceptance criteria. Therefore, most of the requested information (sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.
However, I can extract information related to the device's characteristics and compliance with existing standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Complies with ISO 9693 | Fully complies to ISO 9693 |
| Fulfills essential requirements of European Directive 93/42/ECC concerning medical devices | Fulfills the essential requirements of the European Directive 93/42/ECC |
| High corrosion resistance | Highly corrosion resistant |
| Excellent biocompatibility | Excellent biocompatibility |
| Noble metal content | 78.2% (Gold-Palladium alloy) |
| Free of copper | Free of copper |
| Indication for single crowns, up to long span bridges with two or more pontics | Indication ranges from single crowns up to long span bridges with two or more pontics |
| Suitable for telescopic and milling work | Suitable for telescopic and milling work |
| Veneerable with suitable dental ceramics and dental composites | Can be veneered with suitable dental ceramics and with dental composites |
Note: The document does not describe specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) or a study specifically designed to "prove" the device meets these criteria in a performance study context. Instead, it states the device's inherent properties and its compliance with established industry standards and regulations for dental materials. The "study" in this context would be the internal testing and documentation leading to the certification against ISO 9693 and compliance with the EU directive.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a material submission, not an AI/performance study.
3. 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)
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. 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
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a dental alloy, the "ground truth" would be established through material science testing (e.g., mechanical properties, corrosion resistance, biocompatibility assays) according to international standards (like ISO 9693) and regulatory requirements (EU Directive 93/42/ECC).
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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OCT 2 3 2001
Premarket Notification 510(k)
EURO 50
5. 510 (k) Summary
Submitter of 510(k):
Wieland Edelmetalle GmbH & Co. Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0
| Contact person: | Dr. Gerhard Polzer |
|---|---|
| Phone: | +49-7231-3705-219 |
| Fax: | +49-7231-357959 |
| e-mail: | gerhard.polzer@wieland-dental.de |
2001-07-21 Date of Summary:
Trade name:
EURO 50
Classification name: Alloy, gold based, for clinical use Product code: EJT C.D.R section: 872.3060 Classification: Class II
Legally marketed equivalent device: 510(k) number:
Degubond 4 K 951787
Device description
EURO 50 is a gold-palladium ceramic alloy with high contents of noble metals (78,2%) intended for dental technicians to fabricate dental restorations.
It has an indication which ranges from single crowns up to long span bridges with two or more pontics. It is free of copper and therefore suitable for telescopic and milling work.
EURO 50 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
EURO 50 can be veneered with suitable dental ceramics and with dental composites.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written 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
OCT 2 3 2001
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Edelmetalle GmbH & Company Schwenninger Strabe 13 Pforzheim, GERMANY
Re: K012838
Trade/Device Name: EURO 50 Regulation Number: 872.3060 Regulation Name: Alloy, Gold Based, For Clinical Use Regulatory Class: II Product Code: EJT Dated: August 15, 2001 Received: August 23, 2001
Dear Dr. Polzer:
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 - Dr. Polzer
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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Premarket Notification 510(k)
EURO 50
4. Statement of indication for use
EURO 50 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- . Crowns
- Short span bridges .
- . Long span bridges
and can be used for
- Telescopic and milling work .
EURO 50 can be veneered with suitable dental ceramics as well as with dentalcomposites.
Over-the-Counter Use
Prescription Use Per 21 CFR 801.109)
Susan Russo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital I
510(k) Number KC128538
§ 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.