# K012826: Bioporta G, Model 2052

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Edelmetalle GmbH & Co.
- Decided: Nov 1, 2001 after 70 days
- Product code: EJT (Alloy, Gold-Based Noble Metal)
- Device class: 2
- Regulation: 21 CFR 872.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952122 (1995). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952122: V-Gnathos Plus, Metalor Dental USA Corp. (1995) Summary page 1.

## Most influential descendants
- K023392: Agc Special Alloy (2002), 0 descendants of its own
- K020347: Agc Speziallegierung (2002), 0 descendants of its own

## 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 dental-composites.

Source page: https://510kreport.com/device/K012826
Methodology: https://510kreport.com/methodology