# K070045: Zirblank-PS and Zirblank-FS

- Pathway: 510(k) (Traditional)
- Applicant: Acucera, Inc.
- Decided: Mar 26, 2007 after 81 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: 5 generations back to K830955 (1983). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061804: Zerion Alpha, ; Zerion Beta, Etkon International GmbH (2006) Summary page 1.
- K043472: Medin Tech Zirconia-CP10, SS1000, Medin Tech (2005) Summary page 1.
- K023327: Cynovad Zirkon, Cynovad (2002) Summary page 1.
- K984201: Denzir, Dentronic AB (1999) Summary page 1.
- K013230: Cercon Base, Degussa - Ney Dental, Inc. (2001) Summary page 1.
- (no number) Zerion Alpha: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K050503: Single Use Aspiration Needle NA-201SX-4022, Olympus Medical Systems Corporation (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K081253: Zirdent Cad/Cam Blocks (2008), 1 descendant of its own
- K091362: Ceramic Pedatric Preformed Crown (2009), 0 descendants of its own

## Indications for use
Intended for' use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations. Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Source page: https://510kreport.com/device/K070045
Methodology: https://510kreport.com/methodology