# K050144: Prismatik Ceramic

- Pathway: 510(k) (Traditional)
- Applicant: Glidewell Laboratories
- Decided: Mar 3, 2005 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Avante Micro Crystal® and OPC® Porcelain (Jeneric/Pentron): named in the summary without a submission number
- (no number) Cerabien ZR Porcelain (Noritake): named in the summary without a submission number

## Most influential descendants
- K123613: Synspar Advanced (2013), 0 descendants of its own

## Indications for use
For use in prosthetic dentistry to create porcelain (ceramic) and porcelain (fused-to-metal) prostheses. For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.

Source page: https://510kreport.com/device/K050144
Methodology: https://510kreport.com/methodology