# K091362: Ceramic Pedatric Preformed Crown

- Pathway: 510(k) (Traditional)
- Applicant: Ez-Pedo, Inc.
- Decided: Jun 29, 2009 after 52 days
- Product code: ELZ (Crown, Preformed)
- Device class: 1
- Regulation: 21 CFR 872.3330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K830955 (1983). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931162: King-Hue, Royal Coral, Super-C Artificial Teeth, King Dental Corp. (1993) Summary page 1.
- K041283: Procera Bridge Zirconia, Nobel Biocare AB (2004) Summary page 1.
- K081253: Zirdent Cad/Cam Blocks, C5 Medical Werks, Inc. (2008) Summary page 1.
- (no number) NuSmile Preformed Crowns - Primary Crowns: named in the summary without a submission number

## Indications for use
The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is intended to be used as a functional restoration for primary teeth, including for a badly decayed deciduous (baby) tooth, until the adult tooth erupts. It is not intended for permanent restoration. The EZ-Pedo Inc. Ceramic Pediatric Preformed Crown is indicated for use in infants, children, and adolescents.

Source page: https://510kreport.com/device/K091362
Methodology: https://510kreport.com/methodology