# K012231: Avante Micro Crystal System

- Pathway: 510(k) (Traditional)
- Applicant: Jeneric/Pentron, Inc.
- Decided: Aug 23, 2001 after 38 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K910303 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910303: Sysnpar Porcelain, Jeneric/Pentron, Inc. (1991) Summary page 1.

## Indications for use
Avante Micro Crystal System is a porcelain-fused-to-metal (PFM) restorative system to be layered on conventional PFM alloys to make crowns and multiple-unit bridges. The porcelains can also be used with refractory or foil to create veneer restorations.

Source page: https://510kreport.com/device/K012231
Methodology: https://510kreport.com/methodology