# K101875: BK Blank Model 20,40,65,90

- Pathway: 510(k) (Traditional)
- Applicant: Bk Medent Co., Ltd.
- Decided: Aug 23, 2010 after 48 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.
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. The FDA summary names no predicate by number.

## Indications for use
BK BLANK is indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; namely crowns and bridges.

Source page: https://510kreport.com/device/K101875
Methodology: https://510kreport.com/methodology