(62 days)
No
The 510(k) summary describes a dental alloy material and its intended uses in fabricating dental restorations. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
No
The device is a gold-platinum alloy used by dental technicians to fabricate dental restorations, not a therapeutic device itself.
No
This device is a gold-platinum alloy used by dental technicians to fabricate dental restorations like crowns, bridges, and inlays. It is a material for fabrication, not a device used to diagnose a medical condition.
No
The device description clearly states that BioPorta G is a gold-platinum alloy, which is a physical material used to fabricate dental appliances. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fabricate dental appliances for patients, such as inlays, crowns, bridges, and removable partials. This is a direct application within the patient's mouth for structural and restorative purposes.
- Device Description: The device is a gold-platinum alloy used by dental technicians to create these dental restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a material used to build physical structures for dental restoration.
N/A
Intended Use / Indications for Use
BioPorta G is a gold-platinum alloy that can be used by dental technicians to fabricate der 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
BioPorta G can be veneered with suitable dental ceramics as well as with dental-composites.
In addition BioPorta G, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of BioPorta G are joined to form dental restorations.
Product codes
EJT
Device Description
BioPorta G is a gold-platinum ceramic alloy with high contents of noble metals (97 %) 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. It is free of copper and 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.
BioPorta G 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.
BioPorta G 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.
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)
BioPorta G
Image /page/0/Picture/2 description: The image shows a handwritten sequence of characters. The sequence starts with the letters 'K' and 'O', followed by the number '2'. After '2', there are two '3's, and the sequence ends with '41'. The handwriting is somewhat rough, with varying stroke thicknesses.
5. 510 (k) Summary
DEC 1 0 2002
- Wieland Dental + Technik GmbH & Co. KG Submitter of 510(k): 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:
Trade name:
BioPorta G
2002-10-05
Classification name: Alloy, gold based, for clinical use Product code: EJT C.D.R section: 872.3060 Classification: Class II
Legally marketed V-Gnathos Plus equivalent device: 510(k) number: K952122
Device description
BioPorta G is a gold-platinum ceramic alloy with high contents of noble metals (97 %) 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. It is free of copper and 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.
BioPorta G 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.
BioPorta G 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.
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, with three overlapping profiles facing to the right. The profiles are rendered in black and white.
Public Health Service
ood and Drug Administ 200 Corporate Boulevari ockville MD 20850
Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Co. Schwenninger Strasse 13 D-75179 Pforzheim GERMANY
Re: K023391
Trade/Device Name: BioPorta G 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 yours,
Timothy A Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
510(k) Number (if known):
BioPorta G Device Name:
Indications For Use:
BioPorta G is a gold-platinum alloy that can be used by dental technicians to fabricate der 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
BioPorta G can be veneered with suitable dental ceramics as well as with dental-composites.
In addition BioPorta G, in the shape of wires, can be used for laser welding in operations in which dental alloy parts made of BioPorta G 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✓
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------- | -- |
OR
| Over-The-Counter Use ______ | |
|---|---|
| -- | ----------------------------- |
| (Optional Format 1-2-96) | |
|---|---|
| Susan Runore | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number | k.023391 |