(29 days)
Auropal 50 is a gold-silver casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/Onlays, Crowns, Short span bridges. Auropal 50 can be veneered with dental-composites.
Auropal 50 is a dental gold-silver casting alloy (55% noble metals), intended for dental technicians to fabricate dental restorations. On the basis of it's mechanical properties, Auropal 50 is a Type 4 casting alloy, according to ISO 8891. The indications of Auropal 50 comprise inlays/onlays, crowns and short span bridges. Auropal 50 is highly corrosion resistant and it fully complies with the requirement of the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided text is a 510(k) Premarket Notification for the medical device Auropal 50, a dental gold-silver casting alloy. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (G-Cast Degussa AG) rather than presenting a study to prove performance against specific acceptance criteria using a test set.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The 510(k) summary states:
- Device Description: Auropal 50 is a dental gold-silver casting alloy (55% noble metals), intended for dental technicians to fabricate dental restorations.
- Classification: Type 4 casting alloy, according to ISO 8891, based on its mechanical properties.
- Indications for Use: Inlays/onlays, crowns, and short span bridges. It can be veneered with dental composites.
- Compliance: "Auropal 50 is highly corrosion resistant and it fully complies with the requirement of the international standard ISO 8891 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices."
The FDA's letter (K021733) confirms the substantial equivalence determination based on the information provided by the manufacturer. This process typically relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device, often through a comparison of material properties and adherence to established standards (like ISO 8891 mentioned here) rather than new clinical trials or performance studies with ground truth.
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JUN 2 6 2002
Premarket Notification 510(k)
Auropal 50
5. 510 (k) Summary
| Submitter of 510(k): | Wieland Dental + Technik GmbH & Co. KG |
|---|---|
| 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 |
2002-04-12 Date of Summary:
Trade name:
Auropal 50
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060 Class II
Legally marketed G-Cast equivalent device: Degussa AG Manufacturer:
Device description
Auropal 50 is a dental gold-silver casting alloy (55% noble metals), intended for dental technicians to fabricate dental restorations.
On the basis of it's mechanical properties, Auropal 50 is a Type 4 casting alloy, according to ISO 8891.
The indications of Auropal 50 comprise inlays/onlays, crowns and short span bridges.
Auropal 50 is highly corrosion resistant and it fully complies with the requirement of the international standard ISO 8891 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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 75120 Pforzheim. GERMANY
JUN 2 6 2002
Re: K021733
Trade/Device Name: Auropal 50 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: May 17, 2002 Received: May 28, 2002
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. You must
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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,
Timo 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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Page 1 of 1
| 510(k) Number (if known): | K021733 |
|---|---|
| Auropal 50 |
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Auropal 50 is a gold-silver casting alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- · Inlays/Onlays
- · Crowns
- Short span bridges
Auropal 50 can be veneered with dental-composites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K021733
Prescription Use_ (Per 21 CFR 801.109) ાર
Over-The-Counter Use_.....
(Optional Formal 1-2-96)
§ 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.