(80 days)
Porta Solder 1090 W 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
Porta Solder 1090 W is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a white alloy with high contents of precious metals (Gold, Palladium, Iridium and Silver: 95,5%). Porta Solder 1090 W 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 Euro 50, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta Solder 1090 W 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 describes a 510(k) premarket notification for a dental brazing alloy called "Porta Solder 1090 W." The submission focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or comparative effectiveness studies typically associated with AI/software-as-a-medical-device (SaMD) clearances.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics for an AI/SaMD device are not applicable to this document. The document describes a traditional medical device (a dental alloy).
Here's an analysis based on the information provided, highlighting the sections that are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category (Typical for SaMD) | Specific Criteria (N/A for this device) | Reported Performance (N/A for this device) |
|---|---|---|
| Mechanical Properties | (Not explicitly stated as "acceptance criteria" but implied benchmarks for dental alloys) | "fully complies to the international standard ISO 9333" |
| Corrosion Resistance | (No specific numeric criteria given, but general statement) | "highly corrosion resistant" |
| Biocompatibility | (Implied by regulatory compliance) | Fulfills essential requirements of European directive 93/42/ECC |
| Material Composition | (Not an "acceptance criteria" in the context of a performance study, but a characteristic) | High contents of precious metals (Gold, Palladium, Iridium and Silver: 95.5%) |
| Melting Range/Suitability | (Implicitly matched with ceramic dental alloys) | Suitable for use as filler material in operations where dental alloy parts are joined. Intended as solder before firing for ceramic dental alloys with appropriate melting ranges and compositions. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable as this is a dental alloy, not an AI/SaMD device that would typically have a "test set" in the context of algorithm performance. The "study" referenced in the document is the process of comparing the Porta Solder 1090 W to its predicate device, Argesol-WSF (K 942505), to establish substantial equivalence based on material properties and intended use. There is no mention of a "test set" of patients or data in the way an AI study would define it.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable. The "ground truth" for a dental alloy typically refers to its physical, chemical, and mechanical properties, as measured by standardized tests, and its compliance with industry standards (like ISO 9333) and regulatory requirements. It is not established by expert consensus on clinical findings in the same vein as an AI diagnostic device.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "test set" of clinical cases requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for evaluating the impact of AI assistance on human readers for diagnostic tasks. This device is a dental alloy for fabrication, not a diagnostic tool where human readers interact with AI.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
This information is not applicable. This device is a physical dental alloy, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device is based on:
- Material Science and Engineering Properties: Chemical composition, melting range, corrosion resistance, and mechanical properties determined through laboratory testing according to established international standards (e.g., ISO 9333).
- Regulatory Compliance: Meeting the essential requirements of the European directive 93/42/ECC and demonstrating substantial equivalence to a legally marketed predicate device (Argesol-WSF).
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" for a physical dental alloy in the context of an algorithmic device. The term "training set" is generally used for machine learning models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
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MAY 20 2004
Premarket Notification 510(k)
Porta Solder 1090 W
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: 2004-02-18
Trade name:
PORTA SOLDER 1090 W
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-WSF 510(k) number: K 942505
Device description
Porta Solder 1090 W is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a white alloy with high contents of precious metals (Gold, Palladium, Iridium and Silver: 95,5%).
Porta Solder 1090 W 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 Euro 50, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany.
Porta Solder 1090 W 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 seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle with three lines representing its wings.
MAY 2 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gerhard Polzer Regulatory Affairs Wieland Dental + Technik GmbH & Company KG Schwenninger Strabe 13 D-75179 Pforzheim GERMANY
Re: K040524
Trade/Device Name: Porta Solder 1090 W Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: February 16, 2004 Received: March 1, 2004
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 promarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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 (1 wr t), ice 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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Page 2 -- Dr. Polzer
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: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instille (s 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) rms retect 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), 11 you contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Chris Linsell, Ph.D.
Chiu Lin, Ph.D. 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 !
510(k) Number (if known) : _
Device Name: Porta Solder 1090 W
Indications For Use:
Porta Solder 1090 W 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)
Saset Rums
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number:
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)
§ 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.