# K203072: Franz Zirconia Dental Crown

- Pathway: 510(k) (Traditional)
- Applicant: Franz Biotech, Inc.
- Decided: Jan 19, 2022 after 467 days
- Product code: ELL (Teeth, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.3920
- 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 K910611 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153534: NobelProcera HT ML Full Contour Zirconia Crown, Nobel Biocare AB (2016) Summary page 4.

## Indications for use
Franz Zirconia Dental Crown is indicated for use as main structure of an artificial dental prothesis for partially edentulous patients which require prosthetic oral reconstruction to restore chewing function. Franz Zirconia Dental Crown is indicated for use as single crown that will be cemented to an artificial or natural tooth abutment.

Source page: https://510kreport.com/device/K203072
Methodology: https://510kreport.com/methodology