# K212765: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

- Pathway: 510(k) (Traditional)
- Applicant: Bloomden Bioceramics (HuNan) Co., Ltd.
- Decided: Nov 15, 2021 after 76 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: 3 generations back to K022996 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183304: Prettau, ICE, Z-White zirconia blanks, Zirkonzahn Srl (2019) Summary page 4.

## Most influential descendants
- K260370: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (2026), 0 descendants of its own

## Indications for use
HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, 3D-Pro-ML are intended for the manufacturing of metal-free partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872. UT, UT-C, UT-ML are intended for the manufacturing of metal-free partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products have to be categorized as class 4 according to ISO 6872. The products are suitable for CAD/CAM milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.

Source page: https://510kreport.com/device/K212765
Methodology: https://510kreport.com/methodology