510(k) · Cleared
ClearedBloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bloomden Bioceramics (HuNan) Co., Ltd. · EIH Powder, Porcelain
Cleared on Nov 15, 2021 as substantially equivalent to K183304 (Zirkonzahn Srl, 2019) after a 76-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.
- Decided
- Nov 15, 2021
- Review
- 76 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K022996 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK022996 Vita in-Ceram YZ Cubes for CerecVident · 2002
- 2 generations backK180703 VITA YZ ST and VITA YZ XTVita Zahnfabrik H.Rauter GmbH Co. · 2018
- 1 generation backK183304 Prettau, ICE, Z-White zirconia blanksZirkonzahn Srl · 2019
- This deviceK212765 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK260370 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260370Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K022996 | Vita in-Ceram YZ Cubes for Cerec | Vident | 2002 | — |
| −2 | K180703 | VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH Co. | 2018 | — |
| −1 | K183304 | Prettau, ICE, Z-White zirconia blanks | Zirkonzahn Srl | 2019 | — |
| 0 (this device) | K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2021 | — |
| +1 | K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EIH device
- #1 K192231 Dental Glass Ceramics Blocksscore 15.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K183304 | Prettau, ICE, Z-White zirconia blanksSummary page 4…ulation No. 21 CFR 872.6660 3. Legally Marketed Predicate Device Trade Name PRETTAU®, ICE and Z-WHITE zirconia blanks 510(k) Number K183304 Product Code EIH Manufacturer ZIRKONZAHN SRL Page 1… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K260370 (Bloomden Bioceramics (HuNan) Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K183304.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · EIH
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIH
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIH
1in 2025
MAUDE reports naming product code EIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 63 | 0 | 0 |
| 2008 | 15 | 87 | 0 | 1 |
| 2009 | 15 | 79 | 0 | 0 |
| 2010 | 14 | 89 | 0 | 0 |
| 2011 | 14 | 80 | 0 | 1 |
| 2012 | 9 | 96 | 0 | 0 |
| 2013 | 16 | 107 | 0 | 6 |
| 2014 | 18 | 118 | 0 | 1 |
| 2015 | 23 | 118 | 0 | 0 |
| 2016 | 22 | 187 | 21 | 4 |
| 2017 | 16 | 149 | 0 | 1 |
| 2018 | 10 | 139 | 0 | 2 |
| 2019 | 16 | 125 | 0 | 1 |
| 2020 | 13 | 155 | 0 | 0 |
| 2021 | 17 | 131 | 0 | 22 |
| 2022 | 16 | 89 | 0 | 0 |
| 2023 | 15 | 114 | 0 | 0 |
| 2024 | 28 | 89 | 0 | 7 |
| 2025 | 13 | 84 | 1 | 1 |
| 2026 | 14 | 73 | 0 | — |
What is it indicated for?
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.…
Read the full statement (139 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212765: Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212765
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026