(70 days)
Not Found
No
The description focuses on the material properties and intended uses of a dental alloy, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
This device is a dental alloy used by dental technicians to fabricate dental appliances. It is a material for manufacturing devices, not a therapeutic device itself.
No
The device is a dental alloy used for fabricating dental appliances, not for diagnosing medical conditions.
No
The device description clearly identifies Porta Maximum as a "universal gold-based dental alloy" and an "extra-hard universal alloy with high contents of noble metals." This indicates it is a physical material used for fabrication, not a software product.
Based on the provided information, Porta Maximum is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Porta Maximum's Use: Porta Maximum is a dental alloy used by dental technicians to fabricate dental appliances (inlays, crowns, bridges, etc.) that are placed in the patient's mouth. It is a material used for restoration, not for analyzing biological samples.
The description clearly states its purpose is for manufacturing dental restorations and its use is by dental technicians. This aligns with the definition of a medical device, specifically a dental material, but not an IVD.
N/A
Intended Use / Indications 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.
Product codes
EJT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font.
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.
2
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
3
NOV 01 2001
Image /page/3/Picture/1 description: The image shows a sequence of handwritten characters. The characters are 'K012835'. The characters are written in a bold, dark font, and they are evenly spaced. The background of the image is white.
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 _