(70 days)
Not Found
No
The device description focuses on the material properties and intended uses of a dental alloy, with no mention of AI or ML technology.
No
The device is a material (gold-platinum ceramic alloy) used by dental technicians to fabricate dental appliances. It is not an active device that provides therapy itself, but rather a component of a restorative dental appliance.
No
Explanation: The device, BioPorta G, is a dental alloy used by dental technicians to fabricate dental appliances. It is a material used in the manufacturing process of restorations, not a tool or system used to diagnose a medical condition or disease.
No
The device is a dental alloy, which is a physical material used to fabricate dental appliances, not a software program.
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. This is a direct application within the body (or in contact with the body), not for testing samples taken from the body.
- Device Description: The description focuses on the material properties and its use in creating dental restorations. It doesn't mention any diagnostic function or analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information about a patient's health status.
This device falls under the category of a medical device, specifically a dental material used for restoration. The predicate device listed (K952122 V-Gnathos Plus) is also a dental alloy, further supporting this classification.
N/A
Intended Use / Indications for Use
BioPorta G is a gold-platinum ceramic 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 .
BioPorta G can be veneered with suitable dental ceramics as well as with dentalcomposites.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
BioPorta G is an extra-hard dental alloy with high contents of gold and platinum (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 therefore suitable for telescopic and milling work.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 01 2001
Premarket Notification 510(k)
BioPorta G KO12826
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 |
2001-07-21 Date of Summary:
BioPorta G Trade name:
Classification name: Product code: C.D.R section: Classification:
Alloy, gold based, for clinical use EJT 872.3060 Class II
Legally marketed V-Gnathos Plus equivalent device: 510(k) number: K952122
Device description
BioPorta G is an extra-hard dental alloy with high contents of gold and platinum (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 therefore suitable for telescopic and milling work.
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
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures. The symbol is composed of three curved lines that converge and then separate, creating a sense of movement and connection.
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: K012826
Trade/Device Name: BioPorta G, Model 2052 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.
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
2
Page 2 - Dr. Polzer
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of any I ederal banates requirements, including, but not limited to: registration Tour must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice alle histing (21 CF real 80 +), a may in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form nroduct 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 110(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 If you desire up on the additional of the vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Configiraries wite, 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,
[signature]
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Premarket Notification 510(k)
BioPorta G
4. Statement of indication for use
BioPorta G is a gold-platinum ceramic 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 .
BioPorta G can be veneered with suitable dental ceramics as well as with dentalcomposites.
Susan Puarsg
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices E10(k) Number --10