(70 days)
Porta Maximum is a universal gold-based dental alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/ Onlays . - Partial crowns . - . Crowns - Short span bridges . - Long span bridges . - Removable partials . and can be used for - Telescopic and milling work . Porta Maximum can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.
Porta Maximum is an extra-hard universal alloy with high contents of noble metals (83%), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and removable partials. It is free of copper and therefore suitable for telescopic and milling work. Porta Maximum 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. Porta Maximum can be veneered with low-fusing dental ceramics with high expansion and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
The provided text is a 510(k) Premarket Notification for a dental alloy named "Porta Maximum." This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to existing, legally marketed devices. It does not describe a study involving device performance against acceptance criteria in the manner typically seen for complex medical devices or AI algorithms.
Instead, the submission for "Porta Maximum" focuses on its physical and chemical properties and its intended use, asserting its compliance with international standards (ISO 9693) and European directives. The "acceptance criteria" here are essentially the requirements for substantial equivalence to a predicate device and adherence to established material standards, rather than performance metrics from a clinical study.
Therefore, the requested information elements related to a study (sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance) are not applicable to this type of regulatory submission because an efficacy study of this nature was not performed or required for this type of device.
Below is a table summarizing the "acceptance criteria" as implicitly understood for a dental alloy of this nature, and the reported characteristics of the Porta Maximum, drawing from the provided text.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard (Implicit) | Reported Device Performance (Porta Maximum) |
|---|---|---|
| Substantial Equivalence | Equivalent to legally marketed predicate device (Argistar Bio 75PF, K955973) in terms of indications for use and safety/effectiveness. | Determined substantially equivalent by FDA (K012835). |
| Material Composition | High noble metal content for dental alloys. | 83% noble metals. |
| Intended Use Compatibility | Suitable for a range of dental restorations. | Indication for inlays/onlays, crowns, partial crowns, short span bridges, long span bridges, removable partials. Also suitable for telescopic and milling work. |
| Veneering Compatibility | Compatible with common dental veneering materials. | Can be veneered with low-fusing dental ceramics with high expansion and dental composites. |
| Biocompatibility | Non-toxic and biologically safe for oral use. | Highly corrosion resistant and excellent biocompatibility. |
| Regulatory Compliance | Meets relevant international and regional material standards. | Fully complies with ISO 9693. Fulfills essential requirements of European directive 93/42/ECC concerning medical devices. |
| Physical Properties | "Extra-hard" for durability and functional performance. | Described as an "extra-hard universal alloy." |
| Aesthetic Properties | Provides good basis for aesthetic restorations. | Golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations. |
| Specific Ingredient Concerns | Free of undesirable or allergenic components (e.g., copper for certain applications). | Free of copper, therefore suitable for telescopic and milling work. |
Study Details (Not applicable for this type of device submission)
- Sample size used for the test set and the data provenance: Not applicable. This submission is for a dental alloy, not a device requiring a clinical test set in the traditional sense. The "testing" referred to would be material characterization tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material properties are established through laboratory testing and compliance with standards, not expert consensus on clinical cases.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI or diagnostic tool that involves human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device type would be established by material science standards, lab-based physical and chemical tests (e.g., tensile strength, corrosion resistance, composition analysis), and biocompatibility assessments, rather than clinical outcomes or expert consensus on patient data.
- The sample size for the training set: Not applicable. This device is not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
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NOV 0 1 2001
Premarket Notification 510(k)
Porta Maximum
5. 510 (k) Summary
| Submitter of 510(k): | Wieland Edelmetalle GmbH & Co. |
|---|---|
| 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: 2001-07-21
Porta Maximum Trade name:
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060 Class II
Legally marketed Argistar Bio 75PF equivalent device: K955973 510(k) number:
Device description
Porta Maximum is an extra-hard universal alloy with high contents of noble metals (83%), intended for dental technicians to fabricate dental restorations.
lt has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and removable partials. It is free of copper and therefore suitable for telescopic and milling work.
Porta Maximum 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.
Porta Maximum can be veneered with low-fusing dental ceramics with high expansion and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 1 2001
Dr. Gerhard Polzer Director of Regulatory Affairs Wieland Edelmetalle GmbH & Company Schwenninger Strabe 13 Pforzheim, GERMANY
Re: K012835
Trade/Device Name: Porta Maximum, Model 2066 Regulation Number: 872.3060 Regulation Name: Alloy, Gold Based, for Clinical Use Regulatory Class: II Product Code: EJT Dated: October 18, 2001 Received: October 22, 2001
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: 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
Timol Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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NOV 01 2001
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Premarket Notification 510(k)
Porta Maximum
4. Statement of indication for use
Porta Maximum is a universal gold-based dental alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Inlays/ Onlays .
- Partial crowns .
- . Crowns
- Short span bridges .
- Long span bridges .
- Removable partials .
and can be used for
- Telescopic and milling work .
Porta Maximum can be veneered with low-fusing dental ceramics with high expansion as well as with dental-composites.
Susan Russo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 610(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.