510(k) · Cleared
ClearedCeramax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphadent Co., Ltd. · EIH Powder, Porcelain
Cleared on Sep 5, 2006 as substantially equivalent to K040420 (Dentsply Intl., 2004) after an 8-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it.
- Decided
- Sep 5, 2006
- Review
- 8 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K871808 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK871808 Duceram-Metal-Ceramic Dental Porcelain SystemDegussa Dental, Inc. · 1987
- 1 generation backK040420 Duceram Plus Ceramic SystemDentsply Intl. · 2004
- This deviceK062504 CeramaxAlphadent Co., Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK081200 Dental Porcelain (Glass Powder), Top-Ceram T-1, T1, T2, T3, T4Global Top, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081200Dental Porcelain (Glass Powder), Top-Ceram T-1, T1, T2, T3, T4Global Top, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871808 | Duceram-Metal-Ceramic Dental Porcelain System | Degussa Dental, Inc. | 1987 | — |
| −1 | K040420 | Duceram Plus Ceramic System | Dentsply Intl. | 2004 | — |
| 0 (this device) | K062504 | Ceramax | Alphadent Co., Ltd. | 2006 | — |
| +1 | K081200 | Dental Porcelain (Glass Powder), Top-Ceram T-1, T1, T2, T3, T4 | Global Top, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K040420 | Duceram Plus Ceramic SystemSummary page 1…caiion Name - Porcelain powder lor clinical use 3. Predicate Device: DUCERAM PLUS CERAMIC SYSTEM, Porcelain powders Dentsply International Company. K040420. 4. Description: CeraMax is a dental material product cunp.osed (if Feldspar, Quartz (SiOt), AI,0 3., K2C0 3, NaN('O,. S… | 2004 |
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 |
|---|---|---|---|
| K081200 | Dental Porcelain (Glass Powder), Top-Ceram T-1, T1, T2, T3, T4 | 2008 | 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 3 companies; a new generation was cleared every 16.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081200 (Global Top, Inc., 2008) has gone furthest, with 0 descendants of its own.
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?
CeraMax is indicated for veneering of metal framework and copings for the preparation of crowns and bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062504 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062504: Ceramax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062504
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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