510(k) · Cleared
ClearedGlass Ceramics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · EIH Powder, Porcelain
Cleared on Jan 18, 2006 as substantially equivalent to K980986 (Ivoclar USA, Inc., 1998) and 1 other predicate after a 40-day review. Its family tree reaches back 1 generation to 1998. 19 later devices descend from it.
- Decided
- Jan 18, 2006
- Review
- 40 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K980986 (1998). 2 ancestors in all. 19 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK980986 ProcadIvoclar USA, Inc. · 1998
- This deviceK053438 Glass Ceramics3M Espe AG Dental Products · 2006
- Descendant · cites it directly · 12 of its ownK063511 Ceramill ZIAmann Girrbach America, Inc. · 2007
- Descendant · 2 generations on · 5 of its ownK092513 Rainbow BlockGenoss Co., Ltd. · 2009
- Descendant · 2 generations on · 3 of its ownK152383 Ceramill Zolid FXEmergo Europe Consulting · 2015
- Descendant · 3 generations on · 2 of its ownK151842 Rainbow ShineGenoss · 2016
- Descendant · 3 generations on · 1 of its ownK170050 Z-CAD smileMetoxit AG · 2018
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K063511Ceramill ZIAmann Girrbach America, Inc. · 2007 · cites it directly12descendants
- K092513Rainbow BlockGenoss Co., Ltd. · 2009 · 2 generations on5descendants
- K152383Ceramill Zolid FXEmergo Europe Consulting · 2015 · 2 generations on3descendants
- K151842Rainbow ShineGenoss · 2016 · 3 generations on2descendants
- K170050Z-CAD smileMetoxit AG · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980986 | Procad | Ivoclar USA, Inc. | 1998 | — |
| 0 (this device) | K053438 | Glass Ceramics | 3M Espe AG Dental Products | 2006 | — |
| +1 | K063511 | Ceramill ZI | Amann Girrbach America, Inc. | 2007 | — |
| +2 | K092513 | Rainbow Block | Genoss Co., Ltd. | 2009 | — |
| +2 | K152383 | Ceramill Zolid FX | Emergo Europe Consulting | 2015 | — |
| +3 | K151842 | Rainbow Shine | Genoss | 2016 | — |
| +3 | K170050 | Z-CAD smile | Metoxit AG | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K0113949 | Lava CeramicM / Lava FrameTM Number could not be read | |
| Kept off the family tree | K9204259 | Paradigm TM MZ 100 block Number could not be read Summary page 2…c blocks Predicate Devices: Lava CcrarnmM / Lava FrameTM by 3M ESPE (KOI 13949) Paradigm TM MZ 100 block by 3M ESPE (K9204259) ProCAD® by Ivoclar Vivadent Inc. (presumably K980986) VITABLOCS®v Mark II by VITA Zahnfabrik H… | |
| * | K980986 | ProcadSummary page 2…arnmM / Lava FrameTM by 3M ESPE (KOI 13949) Paradigm TM MZ 100 block by 3M ESPE (K9204259) ProCAD® by Ivoclar Vivadent Inc. (presumably K980986) VITABLOCS®v Mark II by VITA Zahnfabrik H. Rauter GmbH & Co. KG (presumably K022408)… | 1998 |
| * | K022408 | Cerec Vitablocks MK2Summary page 2…ProCAD® by Ivoclar Vivadent Inc. (presumably K980986) VITABLOCS®v Mark II by VITA Zahnfabrik H. Rauter GmbH & Co. KG (presumably K022408) Description for the Premarket Notification GLASS CERAMICS are classified as Porcelain powder… | 2002 |
What descends from it? (19)
See all 195 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.
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?
Manufacture of all-ceramic inlays, onlays, crowns, and veneers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053438: Glass Ceramics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053438
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