Porta IP Solder V-1 is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. It should be used only together with recommended dental alloys with suitable melting ranges and compositions.

Device Description

Porta IP Solder V-1 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with very high contents of precious metals (Gold; Platinum; Iridium and Silver: 99,5%). Porta IP Solder V-1 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 as solder before firing for ceramic dental alloys with appropriate melting ranges and compositions, especially DuoPal 6, Simidur S2 and Simidur KF plus, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta IP Solder V-1 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.

AI/ML Overview

The provided document is a 510(k) summary for a dental brazing alloy, Porta IP Solder V-1. It describes the device, its intended use, and its substantial equivalence to a legally marketed predicate device.

However, the document does not contain information about:

Acceptance criteria for a study proving device performance.
A study demonstrating achievement of acceptance criteria.
Details regarding sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.

Instead, the document focuses on:

Device Description: Porta IP Solder V-1 is a dental brazing alloy, high in precious metals (Gold, Platinum, Iridium, Silver: 99.5%), intended for joining dental alloy parts to form restorations (e.g., bridges) before firing ceramic dental alloys. It is corrosion resistant and complies with ISO 9333 and European directive 93/42/ECC.
Predicate Device: Argesol YPF (K942859).
Regulatory Classification: Class II, Product Code EJT, under 21 CFR 872.3060 (Gold-Based Alloys and Precious Metal Alloys for Clinical Use).
Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information as it is not present in the given text. The 510(k) summary format for this type of medical device (a material like a solder) typically focuses on material composition, intended use, and equivalence to existing devices rather than a performance study with acceptance criteria in the way a diagnostic or AI-driven device might.

Summary

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SEP 1 7 2002

KO22456

Premarket Notification 510(k)

Porta IP Solder V-1

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

Date of Summary: 2002-06-18

PORTA IP SOLDER V-1 Trade name:

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 YPF 510(k) number: K 942859

Device description

Porta IP Solder V-1 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 as solder before firing for ceramic dental alloys with appropriate melting ranges and compositions, especially DuoPal 6, Simidur S2 and Simidur KF plus, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany.

Porta IP Solder V-1 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized abstract symbol to the right and text arranged in a circular fashion around it. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Public Health Service

SEP 1 7 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: K022456

Trade/Device Name: Porta IP Solder V-1 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. 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 (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 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 kn orta IP Solde

Device Name:

Indications For Use:

Porta IP Solder V-1 is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration.

It 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)

Prescription Use	BruintsBik. DVS for Dr. Runner
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
OR	Over-The-Counter Use
	(Optional Format 1-2-96)
510(k) Number	K022456

Regulation Number and Section

§ 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.