(70 days)
BioPortadur is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/ Onlays, Partial crowns, Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work.
BioPortadur is an extra-hard gold casting alloy (96% noble metals), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. In addition, it is suitable for telescopic and milling work. BioPortadur is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided text focuses on regulatory approval for a dental alloy, BioPortadur, and does not contain information about acceptance criteria or a study demonstrating device performance. The text is a 510(k) summary and approval letter, which describes the device, its intended use, and its substantial equivalence to a predicate device, rather than detailed performance data from a specific study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance study details.
- Type of ground truth used.
- Sample size for the training set.
- Method for establishing ground truth for the training set.
The document states that BioPortadur "fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not provide the specific acceptance criteria within ISO 1562 or details of a study that directly verifies and reports performance against those criteria. It only asserts compliance.
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NOV 0 1 2001
Premarket Notification 510(k)
BioPortadur
. . .
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 |
Date of Summary: 2001-07-21
BioPortadur Trade name:
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060 Class II
Legally marketed Argedent 88 equivalent device: 510(k) number: K891600
Device description
BioPortadur is an extra-hard gold casting alloy (96% noble metals), intended for dental technicians to fabricate dental restorations.
It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. In addition, it is suitable for telescopic and milling work.
BioPortadur is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
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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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 1 2001
Dr. Gerhard Polzer Director of Regulatory Affairs Weiland Edelmetalle GmbH & Company Schwenninger Strabe 13 D-75179 Pforzheim, GERMANY
Re: K012831
Trade/Device Name: Bio Portadur, Order-No., 2017 Regulation Number: 872.3060 Regulation Name: Alloy, Gold Based, For Clinical Use Regulatory Class: II Product Code: EJT Dated: October 18, 2001 Received: October 22, 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
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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. 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 . Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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NOV 01 2001
Premarket Notification 510(k)
BioPortadur
4. Statement of indication for use
BioPortadur is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Inlays/ Onlays .
- Partial crowns .
- Crowns .
- Short span bridges .
- Long span bridges .
- Removable partials .
and can be used for
- Telescopic and milling work .
Susan Runner
Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 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.