# K060104: Prismatik Clinical Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Glidewell Laboratories
- Decided: Mar 15, 2006 after 61 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.
19 later devices descend from it; 5 cite it directly.
0 of 20 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) CerconEg base (Dentsply): named in the summary without a submission number
- (no number) LavaTrm Frame (3M): named in the summary without a submission number
- (no number) IPS e~max ZirCAD (Ivoclar-Vivadent): named in the summary without a submission number

## Most influential descendants
- K130924: Bruxzir Shaded (2013), 12 descendants of its own
- K143330: BruxZir Anterior (2014), 6 descendants of its own
- K213425: BruxZir Esthetic (2021), 2 descendants of its own
- K123545: Incoris Tzi (2013), 2 descendants of its own
- K162888: Cercon (2017), 1 descendant of its own

## Indications for use
For use in prosthetic dentistry to create porcelain (ceramic) 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/K060104
Methodology: https://510kreport.com/methodology