# K193434: Vita Lumex AC

- Pathway: 510(k) (Traditional)
- Applicant: Vita Zahnfabrik GmbH H Rauter & CO
- Decided: Jul 21, 2020 after 223 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: 1 generation back to K060441 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060441: Vita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model VX60 XXXX, VX61 XXXX, VX62 XXXX; Vita VM 9, Model NX98, Vident (2006) Summary page 5.

## Indications for use
VITA Lumex® AC is used to veneer the following: • Full and partial veneering of zirconia • Full and partial veneering of lithium disilicate • Partial veneering of feldspar ceramic • Reconstruction without a substructure Materials: • Zirconia substructures (CTE approx. 10.0 to 10.5 x 10-6 K-1) • Glass-ceramic substructures (CTE approx. 9.0 to 10.5 x 10-6 K-1)

Source page: https://510kreport.com/device/K193434
Methodology: https://510kreport.com/methodology