510(k) · Cleared
ClearedRainbow Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genoss Co., Ltd. · EIH Powder, Porcelain
Cleared on Oct 9, 2009 as substantially equivalent to K061851 (Zirkonzahn GmbH, 2006) and 1 other predicate after a 53-day review. Its family tree reaches back 3 generations to 1998. 5 later devices descend from it.
- Decided
- Oct 9, 2009
- Review
- 53 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K980986 (1998). 6 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK980986 ProcadIvoclar USA, Inc. · 1998
- 2 generations backK053438 Glass Ceramics3M Espe AG Dental Products · 2006
- 1 generation backK063511 Ceramill ZIAmann Girrbach America, Inc. · 2007
- This deviceK092513 Rainbow BlockGenoss Co., Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK151842 Rainbow ShineGenoss · 2016
- Descendant · 2 generations on · 1 of its ownK160079 rainbow ShineGenoss Co., Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK232174 rainbowTM Multi-Layer Block / bright 3-Layer / bright MonoGenoss Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK151723 Rainbow TransGenoss · 2015
- Descendant · cites it directly · 0 of its ownK151844 Rainbow ShadeGenoss · 2015
Most influential descendants
Showing 5 of 5 · See all- K151842Rainbow ShineGenoss · 2016 · cites it directly2descendants
- K160079rainbow ShineGenoss Co., Ltd. · 2016 · 2 generations on1descendant
- K232174rainbowTM Multi-Layer Block / bright 3-Layer / bright MonoGenoss Co., Ltd. · 2024 · 3 generations on0descendants
- K151723Rainbow TransGenoss · 2015 · cites it directly0descendants
- K151844Rainbow ShadeGenoss · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980986 | Procad | Ivoclar USA, Inc. | 1998 | — |
| −2 | K053438 | Glass Ceramics | 3M Espe AG Dental Products | 2006 | — |
| −1 | K063511 | Ceramill ZI | Amann Girrbach America, Inc. | 2007 | — |
| 0 (this device) | K092513 | Rainbow Block | Genoss Co., Ltd. | 2009 | — |
| +1 | K151842 | Rainbow Shine | Genoss | 2016 | — |
| +2 | K160079 | rainbow Shine | Genoss Co., Ltd. | 2016 | — |
| +3 | K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | Genoss Co., Ltd. | 2024 | — |
| +1 | K151723 | Rainbow Trans | Genoss | 2015 | — |
| +1 | K151844 | Rainbow Shade | Genoss | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K061851 | Zirkonzahn IceSummary page 1…nbow Block Common name: Dental framne material for Dental prosthesis Classification name: Porcelain, powder for clinical use 3. Predicated Device K061851 Zirkonzahn Ice K063511 Ceramill Zi Blank 4. Description Rainbow Block is a dental ceramic made out of zir… | 2006 |
| * | K063511 | Ceramill ZISummary page 1…Dental framne material for Dental prosthesis Classification name: Porcelain, powder for clinical use 3. Predicated Device K061851 Zirkonzahn Ice K063511 Ceramill Zi Blank 4. Description Rainbow Block is a dental ceramic made out of zirconia. Rainbow Block is milled… | 2007 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Rainbow Block is used in the manufacture of a dental core through milling by machine (MAD/MAM or CAD/CAM) followed by sintering.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092513 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092513: Rainbow Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092513
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