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 Mar 30, 2026 as substantially equivalent to K212765 (Bloomden Bioceramics (HuNan) Co., Ltd., 2021) after a 53-day review. Its family tree reaches back 4 generations to 2002.
- Decided
- Mar 30, 2026
- Review
- 53 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K022996 (2002). No later device cites it as a predicate yet.
- Root · 4 generations backK022996 Vita in-Ceram YZ Cubes for CerecVident · 2002
- 3 generations backK180703 VITA YZ ST and VITA YZ XTVita Zahnfabrik H.Rauter GmbH Co. · 2018
- 2 generations backK183304 Prettau, ICE, Z-White zirconia blanksZirkonzahn Srl · 2019
- 1 generation backK212765 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2021
- This deviceK260370 Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankBloomden Bioceramics (HuNan) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K022996 | Vita in-Ceram YZ Cubes for Cerec | Vident | 2002 | — |
| −3 | K180703 | VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH Co. | 2018 | — |
| −2 | K183304 | Prettau, ICE, Z-White zirconia blanks | Zirkonzahn Srl | 2019 | — |
| −1 | K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2021 | — |
| 0 (this device) | K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2026 | — |
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 |
|---|---|---|---|
| * | K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSummary page 6…evice Trade Name Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank 510(k) Number K212765 Product Code EIH Manufacturer Bloomden Bioceramics (HuNan) Co., Ltd 4. Device Description Bloomden D… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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, 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…
Read the full statement (165 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260370: 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/K260370
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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