510(k) · Cleared
ClearedAmber Mill Q Series & Amber Mill Direct Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hass Corp. · EIH Powder, Porcelain
Cleared on Aug 26, 2021 as substantially equivalent to K160262 (Institut Straumann AG, 2016) after a 330-day review. Its family tree reaches back 2 generations to 2005. 1 later device descends from it.
- Decided
- Aug 26, 2021
- Review
- 330 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051705 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK051705 Ips E.Max Cad/Ips E.Max ZircadIvoclar Vivadent, Inc. · 2005 · Recalled
- 1 generation backK160262 n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG · 2016
- This deviceK202952 Amber Mill Q Series & Amber Mill Direct SeriesHass Corp. · 2021
- Descendant · cites it directly · 0 of its ownK233016 Dental Glass CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K233016Dental Glass CeramicsShenzhen Yurucheng Dental Materials Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051705 | Ips E.Max Cad/Ips E.Max Zircad | Ivoclar Vivadent, Inc. | 2005 | 10 |
| −1 | K160262 | n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, | Institut Straumann AG | 2016 | — |
| 0 (this device) | K202952 | Amber Mill Q Series & Amber Mill Direct Series | Hass Corp. | 2021 | — |
| +1 | K233016 | Dental Glass Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K160262 | n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Summary page 4…• Product Code: EIH • Classification regulation: 21 CFR 872.6660 4. Primary Predicate Device: Straumann n!ce Glass-Ceramic Blocks by Institut Straumann AG (K160262) 5. Description: Amber Mill Q Series and Amber Mill Direct Series are a lithium disilicate ceramic to be supplied in the f… | 2016 |
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 |
|---|---|---|---|
| K233016 | Dental Glass Ceramics | 2023 | 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 16 years and passes through 3 companies; a new generation was cleared every 10.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K233016 (Shenzhen Yurucheng Dental Materials Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K160262.
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?
Once finalized into a suitable design, the Amber Mill Q Series and Amber Mill Direct Series are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202952 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202952: Amber Mill Q Series & Amber Mill Direct Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202952
Report an extraction error
Are you the manufacturer?
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