# K123613: Synspar Advanced

- Pathway: 510(k) (Abbreviated)
- Applicant: Ardent, Inc.
- Decided: Feb 20, 2013 after 89 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: 3 generations back to K940252 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050144: Prismatik Ceramic, Glidewell Laboratories (2005) Summary page 1.
- K071848: Ips Inline Pom System, Ivoclar Vivadent, Inc. (2007) Summary page 1.

## Indications for use
Synspar Advance Pressable Ceramic (Pellets) is a leucite ceramic system for: Press-an-Metal Restorations * Single unit fully anatomical crowns in the anterior and posterior regions * Fully anatomical splinted crowns and bridges in the anterior and posterior regions * Compatible with dental alloys in the GTE range 13.6-14.6 x 101IK (25-500*C). Alloys should be copper-free and contain less than 14% silver. Pressed All-ceramic Restorations *Adhesively cemented single unit anterior all-ceramic restorations (crowns, inlays, onlays, veneers)

Source page: https://510kreport.com/device/K123613
Methodology: https://510kreport.com/methodology