(27 days)
Portalloy 54 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, Removable partials and can be used for Telescopic and milling work. Portalloy 54can be veneered with suitable dental ceramics as well as with dentalcomposites.
PORTALLOY 54 is a gold-palladium ceramic alloy with high contents of noble metals (85,3%) 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. PORTALLOY 54 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. PORTALLOY 54 can be veneered with suitable dental ceramics and with dental composites.
This document is a 510(k) Premarket Notification for a dental alloy named "Portalloy 54". It describes the device, its intended use, and states that it has been deemed substantially equivalent to a legally marketed predicate device.
Based on the provided text, the document focuses on the regulatory clearance process for a dental material and does not contain information about acceptance criteria or a study proving that a device meets such criteria.
Specifically, the document includes:
- Device Description: Portalloy 54 is a gold-palladium ceramic alloy with high noble metal content (85.3%) for dental restorations like crowns, short/long span bridges, and removable partials. It's also suitable for telescopic and milling work and can be veneered with dental ceramics and composites.
- Regulatory Compliance: It states that the device complies with international standard ISO 9693 and essential requirements of European directive 93/42/ECC. This is a declaration of compliance with standards rather than a report of a specific performance study against acceptance criteria.
- Substantial Equivalence: The FDA's letter states that "the device is substantially equivalent... to legally marketed predicate devices." This is the core of a 510(k) submission, where the new device is shown to be as safe and effective as a previously cleared device, often without new clinical performance data if similarities are strong enough.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this information is not present in the provided text. The document is a regulatory submission for a dental alloy, not a performance study report for an AI/medical device with specific acceptance metrics.
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Premarket Notification 510(k)
Portalloy 54
વડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્
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: Phone: Fax: e-mail:
Dr. Gerhard Polzer +49-7231-3705-219 +49-7231-357959 gerhard.polzer@wieland-dental.de
Date of Summary:
Trade name:
PORTALLOY 54
2002-04-04
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060 Class II
Legally marketed V-Deltalloy equivalent device: K 944572 510(k) number:
Device description
PORTALLOY 54 is a gold-palladium ceramic alloy with high contents of noble metals (85,3%) 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.
PORTALLOY 54 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.
PORTALLOY 54 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 seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing to the left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2002
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 75120 Pforzheim, Germany
Re: K021242
Trade/Device Name: Portalloy 54 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: Class II Product Code: EJT Dated: April 16, 2002 Received: April 19, 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.
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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 comply with all the Act's requirements, including, but not limited to: aggistration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing registerior and monts 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) 594-4659. 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,
Patricio Cucurella / Kor
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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Page
1021242
510(k) Number (if known):
Portalloy 54
Device Name:___
Indications For Use:
Portalloy 54 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
• Removable partials
and can be used for
· Telescopic and milling work
Portalloy 54can be veneered with suitable dental ceramics as well as with dentalcomposites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_r (Per 21 CFR 801.109) ાર
Over-The-Counter Use_____
Susan Runne
(Optional Formal 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 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.