# K152274: MSCB-001

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Mar 25, 2016 after 226 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 K022408 (2002). 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)
- K022408: Cerec Vitablocks MK2, B.B.'S Prophy Shop (2002) Summary page 4.

## Indications for use
1. Metal free indirect restorations: full crown, inlays, onlays, laminated veneer

Source page: https://510kreport.com/device/K152274
Methodology: https://510kreport.com/methodology