(61 days)
EURO 45 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 45 can be veneered with suitable dental ceramics as well as with dentalcomposites.
EURO 45 is a gold-palladium ceramic alloy with high contents of noble metals (79,5%) intended for dental technicians to fabricate dental restorations. lt 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 45 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 45 can be veneered with suitable dental ceramics and with dental composites.
This 510(k) premarket notification is for a dental alloy, not an AI/ML-enabled medical device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, standalone performance, ground truth establishment methods, or training set details) are not applicable to this document. The document describes a traditional medical device (dental alloy) and its compliance with established standards for materials.
However, I can extract the relevant information regarding the acceptance criteria and how the device meets them based on the provided text.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| High contents of noble metals | 79.5% noble metals |
| Corrosion resistant | Highly corrosion resistant |
| Biocompatibility | Excellent biocompatibility |
| Compliance with ISO 9693 | Fully complies with ISO 9693 |
| Compliance with European directive 93/42/ECC | Fulfills the essential requirements of 93/42/ECC |
| Suitable for veneering with dental ceramics | Can be veneered with suitable dental ceramics |
| Suitable for veneering with dental composites | Can be veneered with suitable dental composites |
| Free of copper | Free of copper (suitable for telescopic and milling work) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in the provided document. The basis of testing is typically material property evaluation rather than a "test set" in the context of data-driven models.
- Data provenance: Not explicitly stated as "country of origin" for data. The testing is implied to be conducted by the manufacturer, Wieland Edelmetalle GmbH & Co. (Germany), to meet international standards. This would typically involve laboratory testing of material batches.
- Retrospective/Prospective: Not applicable in the context of material property testing for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a dental alloy's material properties (e.g., corrosion resistance, noble metal content, biocompatibility) is established through standardized laboratory testing and analytical chemistry, not expert consensus in the way an AI model's output would be adjudicated.
4. Adjudication method for the test set
Not applicable. Material properties are measured against objective standards, not adjudicated by experts in a concensus method.
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. This is for a dental alloy, not an AI/ML-enabled medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a dental alloy, not an AI/ML-enabled medical device.
7. The type of ground truth used
The ground truth used for this device would be:
- Physical and chemical measurements against International Standards (specifically ISO 9693 for dental casting alloys).
- Compliance with European Directive 93/42/ECC through demonstration of essential requirements met.
- Laboratory testing results (e.g., noble metal content by analytical methods, corrosion testing, biocompatibility assays).
8. The sample size for the training set
Not applicable. This is for a dental alloy, not an AI/ML-enabled medical device.
9. How the ground truth for the training set was established
Not applicable. This is for a dental alloy, not an AI/ML-enabled medical device.
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OCT 2 3 2001
Premarket Notification 510(k)
EURO 45
5. 510 (k) Summary
| Submitter of 510(k): | Wieland Edelmetalle GmbH & Co. |
|---|---|
| Schwenninger Str. 13 | |
| D-75179 Pforzheim | |
| Germany | |
| Phone: +49-7231-3705-0 |
Dr. Gerhard Poizer Contact person: +49-7231-3705-219 Phone: +49-7231-357959 Fax: gerhard.polzer@wieland-dental.de e-mail:
Date of Summary:
Trade name:
EURO 45
2001-07-21
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060 Class II
Legally marketed equivalent device: 510(k) number:
Eureka Plus K 944887
Device description
EURO 45 is a gold-palladium ceramic alloy with high contents of noble metals (79,5%) intended for dental technicians to fabricate dental restorations.
lt 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 45 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 45 can be veneered with suitable dental ceramics and with dental composites.
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OCT 2 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Edelmetalle GmbH & Company Schwenninger Strabe 13 Pforzheim, GERMANY
Re: K012840
Trade/Device Name: Euro 45, Order-No; 2064 Regulation Number: 872.3060 Regulation Name: Alloy, Gold Based, For Clinical Use Regulatory Class: II Product Code: EJS and EJT Dated: August 23, 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 I ou must comply with an are reveling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Pat 807), laqslity systems (QS) regulation (21 CFR Part 820); and if requirences as set form in the quality sign control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
21 CFN 1000-1050.
This letter will allow you to begin marketing your device as described in your Section I his letter will anow you to begin manoung of substantial equivalence of your device to J10(K) premarket notification. Vice 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 II you desire specific ad 1.00 for in vitro diagnostic devices), please contact the and additionally 21 CFR Fall 609110 113. Additionally, for questions on the promotion and Office of Colliphiance at (301) as contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Anotification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (21GFR Part 00197). Vision of Small Manufacturers, International and the Act may be obtained from the Brumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Tim 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 45
4. Statement of indication for use
EURO 45 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients.
KO12840
It is intended for manufacturing
- . Crowns
- Short span bridges .
- Long span bridges .
and can be used for
- Telescopic and milling work .
EURO 45 can be veneered with suitable dental ceramics as well as with dentalcomposites.
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use.
Susan Ruoss
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number
§ 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.