# K112044: Anaxblend Model 20XXX (Several), Anaxgum Model 25XXX (U), Mock-UP Direct Model 240XXX (U), Mock-UP Direct Flow Model 24A

- Pathway: 510(k) (Abbreviated)
- Applicant: Anaxdent GmbH
- Decided: Jan 26, 2012 after 192 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
- full or partial facing of fixed metal-based crowns and bridges; - anterior and posterior crowns; - inlays, onlays; - facing of removable combined restorations (telescopic/conical crowns and attachment retained dentures); - Characterization of dentures - Esthetic rehabilitation of gingival parts in case of dental restorations with severe bone loss; - Facing of the gingival area of removable combined restorations (telescopic/conical crowns and attachment-retained dentures); - Characterization of dentures - mock-ups; - direct anterior and posterior fillings of the classes I, II, III, and V (Black); - indirect restorations as inlays, onlays and veneers; - extended fissure sealing of molars and premolars; - core build-ups; - splinting of loose teeth; - shape and color corrections to improve the esthetic appearance

Source page: https://510kreport.com/device/K112044
Methodology: https://510kreport.com/methodology