# K260370: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

- Pathway: 510(k) (Traditional)
- Applicant: Bloomden Bioceramics (HuNan) Co., Ltd.
- Decided: Mar 30, 2026 after 53 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: 4 generations back to K022996 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212765: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Bloomden Bioceramics (HuNan) Co., Ltd. (2021) Summary page 6.

## Indications for use
HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML, HTP-plus, STP, STP-C, STP-ML, SHTP, SHTP-C, SHTP-ML, 3DP-Pro-ML are indicated for the treatment of partial or total loss of anatomical crown in the anterior and posterior tooth regions, from single crown to up to 14-unit teeth, i.e. the manufacturing of _anatomically reduced and fully anatomical (monolithic) crowns in the anterior and posterior tooth range (e.g. single-tooth crowns, inlays, onlays, veneers); _ anatomically reduced and fully anatomical (monolithic) bridges (up to 14 units) in the anterior and posterior tooth range. UT, UT-C, UT-ML, UTP, UTP-C, UTP-ML are indicated for the treatment of partial or total loss of anatomical crown in the anterior and posterior tooth regions, from single crown to up to 3-unit teeth, i.e. the manufacturing of _ anatomically reduced and fully anatomical (monolithic) crowns in the anterior and posterior tooth range (e.g. single-tooth crowns, inlays, onlays, veneers); _ anatomically reduced and fully anatomical (monolithic) bridges (up to 3 units) in the anterior and posterior tooth range.

Source page: https://510kreport.com/device/K260370
Methodology: https://510kreport.com/methodology