(73 days)
Porta Reflex is a gold-platinum 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 Reflex can be veneered with suitable dental ceramics as well as with dental-composites.
Porta Reflex is an extra-hard gold-platinum ceramic alloy with high contents of noble metals (97,7%), intended for dental technicians to fabricate dental restorations. It 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 Reflex 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 Reflex can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations.
Here's an analysis of the provided 510(k) summary for the Porta Reflex device, focusing on the acceptance criteria and study information:
This document, K040672 for "Porta Reflex," is a 510(k) Premarket Notification. For this type of device (a dental alloy), 510(k)s typically demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria that one might see for AI/ML-based diagnostic devices.
Therefore, the structure of the request for acceptance criteria and study data needs to be interpreted in the context of this specific device and filing type. The "study" here is primarily a demonstration of compliance with established standards and comparison to a predicate, not a clinical effectiveness trial in the way that an AI diagnostic would have.
Acceptance Criteria and Reported Device Performance
Given that this is a dental alloy and a 510(k) submission, the "acceptance criteria" are typically compliance with recognized standards and demonstration of properties comparable to a predicate device, rather than specific sensitivity/specificity targets.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with International Standard ISO 9693 | "Porta Reflex... fully complies to the international standard ISO 9693" |
| Compliance with European Directive 93/42/ECC | "Porta Reflex... fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." |
| High Corrosion Resistance | "Porta Reflex is highly corrosion resistant" |
| Excellent Biocompatibility | "Porta Reflex... has an excellent biocompatibility." |
| Suitable for Vennering with suitable dental ceramics | "Porta Reflex can be veneered with suitable dental ceramics..." |
| Suitable for Vennering with dental composites | "...and with dental composites" |
| Golden yellow color (aesthetic basis) | "...the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations." |
| No copper (for telescopic/milling work) | "It is free of copper and therefore suitable for telescopic and milling work." |
| Legally Marketed Equivalent Device (Predicate) | Porta Geo Ti (K023389) -- The entire 510(k) aims to demonstrate equivalence to this predicate. |
Study Information
For this type of device, the "study" is more akin to engineering and materials testing, and a comparison to an existing predicate, rather than a clinical trial with human subjects testing AI performance.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes or data provenance for any specific mechanical or material property tests. This information would typically be detailed in the full submission, which is not provided, but often isn't explicitly summarized in the 510(k) summary itself for materials devices. The "tests" here are standard material characterization tests, likely conducted in a lab setting, not on patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is not a diagnostic device involving expert interpretation of medical images or patient data. The "ground truth" would be material properties established via standardized lab measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a clinical study requiring adjudication of diagnoses.
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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 is not an AI/ML device, nor a diagnostic device that would involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm/AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device would be established through laboratory material characterization tests conforming to ISO 9693 and other relevant engineering standards. These tests measure properties like tensile strength, corrosion resistance, biocompatibility, etc.
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The sample size for the training set
- Not applicable. There is no AI/ML model for which to define a training set. If interpreted in a broader sense of "development data," it would refer to the materials used in R&D and optimization, but this is not specified.
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How the ground truth for the training set was established
- Not applicable. There is no AI/ML model for which to define a training set. The "ground truth" for development would be the target material properties and performance characteristics defined by engineering specifications and industry standards.
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MAY 2 7 2004
Premarket Notification 510(k)
Porta Reflex
510 (k) Summary 5.
| 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 |
2004-02-16 Date of Summary:
Trade name:
Porta Reflex
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060 Class II
Legally marketed equivalent device: Porta Geo Ti K 023389 510(k) number:
Device description
Porta Reflex is an extra-hard gold-platinum ceramic alloy with high contents of noble metals (97,7%), intended for dental technicians to fabricate dental restorations.
It 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 Reflex 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 Reflex can be veneered with suitable dental ceramics 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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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 2004
Dr. Gerhard Polzer Regulatory Affairs Wieland Dental+ Technik GmbH & Company KG Schwenninger Strabe 13 D-75 179 Pforzheim GERMANY
Re: K040672
Trade/Device Name: Porta Reflex Regulation Number: 872.3060 Regulation Namc: Gold-Based Alloys and Precious Metal Alloys for Clinical USE Regulatory Class: II Product Code: EJT Dated: February 16, 2004 Received: March 15, 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 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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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 modified in any Federal statutes and regulations administered by other Federal agencies. or the rice of any - 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 home (21 CF R Part 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) This letter whilanov. Jo The FDA finding of substantial equivalence of your device to a premaired notified predicate device results in a classification for your device and thus, permits your device to procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you decire 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 maj obtain 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,
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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510(k) Number (if known): K040672
Device Name: Porta Reflex
Indications For Use:
Porta Reflex is a gold-platinum 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 Reflex can be veneered with suitable dental ceramics as well as with dental-composites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rumm
ivision of Ar
510(k) Number: K040672
(Optional Format 3-10-98)
§ 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.