(63 days)
Not Found
No
The device description and intended use clearly define the device as a gold casting alloy for fabricating dental appliances, with no mention of software, algorithms, or any technology related to AI or ML.
No.
The device is a gold casting alloy used by dental technicians to fabricate dental appliances; it is a material for manufacturing, not a therapeutic device itself.
No
The device is a gold casting alloy used by dental technicians to fabricate dental appliances/restorations, not to diagnose medical conditions.
No
The device description clearly states it is a gold casting alloy, which is a physical material used to fabricate dental appliances. It does not describe any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Portadur P2 is a gold casting alloy used by dental technicians to fabricate dental appliances for patients. This involves creating physical restorations that are placed in the mouth.
- Device Description: The description reinforces that it's a material used to create dental restorations and for laser welding of dental alloy parts.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological or pathological state, or to determine compatibility with potential recipients. Portadur P2 does not perform any such diagnostic testing on bodily specimens.
The device is a medical device (specifically a dental material), as indicated by its compliance with the European directive 93/42/ECC concerning medical devices. However, it falls under the category of materials used to create medical devices, not a diagnostic device itself.
N/A
Intended Use / Indications for Use
Portadur P2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Inlays/ Onlays
- Crowns
- Short span bridges
- Long span bridges
- Removable partials
and can be used for
- Telescopic and milling work
In addition Portadur P2, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of identical or comparable alloys are joined to form dental restorations.
Product codes
EJT
Device Description
Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), 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 to removable partials. In addition, it is suitable for telescopic and milling work as well as for laser welding. For this application it will be delivered in the shape of laser welding wires.
Portadur P 2 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
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
Premarket Notification 510(k)
Portadur P 2
5. 510 (k) Summary
DEC 11 2002
Wieland Dental + Technik GmbH & Co. Submitter of 510(k): Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0
2002-10-05
| Contact person: | Dr. Gerhard Polzer |
|---|---|
| Phone: | +49-7231-3705-219 |
| Fax: | +49-7231-357959 |
| e-mail: | gerhard.polzer@wieland-dental.de |
Date of Summary:
Trade name: Portadur P 2
Classification name: Alloy, gold based, for clinical use Product code: EJT C.D.R section: 872.3060 Classification: Class II
Legally marketed Aurofluid 3 equivalent device: 510(k) number: K911539
Device description
Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), 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 to removable partials. In addition, it is suitable for telescopic and milling work as well as for laser welding. For this application it will be delivered in the shape of laser welding wires.
Portadur P 2 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.
1
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 features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.
DEC 1 1 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. KG Schwenninger Strasse 13 D-75179 Pforzheim GERMANY
Re: K023395
Trade/Device Name: Portadur P2 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: October 05, 2002 Received: October 09, 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.
2
Page 2 - Dr. Gerhard 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 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), 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 vours.
Paltina Everett ffe
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
3
| 10(k) Number (if known): | K023395 |
|---|---|
| -------------------------- | --------- |
Portadur P2
Device Name:
5
Indications For Use:
Portadur P2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients.
It is intended for manufacturing
- Inlays/ Onlays
- Crowns
- Short span bridges
- Long span bridges
- Removable partials
and can be used for
- Telescopic and milling work ●
In addition Portadur P2, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of identical or comparable alloys are joined to form dental restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) Over-The-Counter Use_____
(Optional Formal 1-2-96)
sion Sign-Off) on of Anesthesiology, General Hospital, tion Control, Dental Devices
OR
510(k) Number: K023571