(48 days)
Porta OP Solder W-2 is intended for use as a secondary solder for dental casting alloys, as well as a solder after firing for dental ceramic alloys, in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. lt should be used only together with recommended dental alloys with suitable melting ranges and compositions.
Porta OP Solder W-2 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with high contents of precious metals (Gold, Platinum and Silver: 88,0%). Porta OP Solder W-2 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended for use as primary solder for dental casting alloys, and as solder after firing for dental ceramic alloys should have appropriate melting ranges and compositions, especially recommended are AGC® Special alloy, Porta Geo Ti, BioPorta G, Porta SMK 82, Portalloy 54, Euro 50, DuoPal 6, Simidur S1S, Simidur S2, Simidur KF plus, BioPortadur, Portadur P 2, Auropal 60, and Auropal 50, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta OP Solder W-2 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
The provided text is a 510(k) summary for a dental brazing alloy, Porta OP Solder W-2. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance testing against quantitative metrics or human clinical effectiveness.
The document discusses compliance with:
- ISO 9333: International standard for dental brazing alloys.
- European directive 93/42/ECC: Concerning medical devices.
- The device's high corrosion resistance.
These are regulatory and material standards, but the document does not present them as "acceptance criteria" met by a "study" in the way one would describe a performance evaluation with specific data points for accuracy, sensitivity, specificity, or human reader improvement, as requested in the prompt.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or multi-reader multi-case studies, because this information is not present in the provided text. The text is a regulatory submission focused on substantial equivalence based on material composition and general compliance with existing standards, not on specific performance data from a clinical or analytical study as commonly described for AI/diagnostic devices.
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Premarket Notification 510(k)
5. 510 (k) Summary
Wieland Dental + Technik GmbH & Co. KG Submitter of 510(k): 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: 2002-06-18
Trade name: PORTA OP SOLDER W-2
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060 Class II
Legally marketed equivalent device: Argesol 720 510(k) number: K 943779
Device description
Porta OP Solder W-2 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with high contents of precious metals (Gold, Platinum and Silver: 88,0%).
Porta OP Solder W-2 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges.
It is intended for use as primary solder for dental casting alloys, and as solder after firing for dental ceramic alloys should have appropriate melting ranges and compositions, especially recommended are AGC® Special alloy, Porta Geo Ti, BioPorta G, Porta SMK 82, Portalloy 54, Euro 50, DuoPal 6, Simidur S1S, Simidur S2, Simidur KF plus, BioPortadur, Portadur P 2, Auropal 60, and Auropal 50, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany.
Porta OP Solder W-2 is highly corrosion resistant. It fully complies to the international standard ISO 9333 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 features a stylized depiction of a human figure in profile, composed of three curved lines. The figure is positioned to the right of a circular emblem containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.
Public Health Service
SEP 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Company KG Schwenninger Straße 13 D-75179 Pforzheim GERMANY
Re: K022454
Trade/Device Name: Porta OP Solder W-2 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 22, 2002 Received: July 26, 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.
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Page 2 – Dr. Gerhard 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 (OS) 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,
Patricia Cucentiffe
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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 Porta OP Solder W-2
Device Name:_
Indications For Use:
Porta OP Solder W-2 is intended for use as a secondary solder for dental casting alloys, as well as a solder after firing for dental ceramic alloys, in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration.
lt should be used only together with recommended dental alloys with suitable melting ranges and compositions.
(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 Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K0224577 |
|---|---|
| ---------------- | ---------- |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Optional Format 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.