# K061809: Artegral Imcrown

- Pathway: 510(k) (Traditional)
- Applicant: Merz Dental GmbH
- Decided: Sep 13, 2006 after 78 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
212 later devices descend from it; 2 cite it directly.
0 of 213 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) Temporary Crown and Bridge Resin: named in the summary without a submission number

## Most influential descendants
- K071548: Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored (2007), 211 descendants of its own
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own
- K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own

## Indications for use
artegral inCrown is indicated for use as a provisional anterior crown when fitted with the CEREC 3D and inLab.

Source page: https://510kreport.com/device/K061809
Methodology: https://510kreport.com/methodology