# K102128: Vitablocs

- Pathway: 510(k) (Abbreviated)
- Applicant: Vita Zahnfabrik H.Rauter GmbH & Co.
- Decided: Aug 11, 2010 after 13 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K122269: Enamic (2012), 3 descendants of its own
- K243940: VITA YZ Multi Translucent (2025), 0 descendants of its own
- K153645: VITA ENAMIC Implant Solutions (IS) (2016), 0 descendants of its own
- K130654: Crystal Ultra (2013), 0 descendants of its own

## Indications for use
Vitablocs® are indicated for use as a dental restoration including inlays, onlays, veneers, crowns and bridges. For use by or on the order of a dental professional such as DDS or DMVD. Not for use. by the general public or OTC.

Source page: https://510kreport.com/device/K102128
Methodology: https://510kreport.com/methodology