510(k) · Cleared
ClearedCercon HT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply International, Inc. · EIH Powder, Porcelain
Cleared on Nov 9, 2011 as substantially equivalent to K013230 (Degussa - Ney Dental, Inc., 2001) and 1 other predicate after a 105-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- Nov 9, 2011
- Review
- 105 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K013230 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK013230 Cercon BaseDegussa - Ney Dental, Inc. · 2001
- 1 generation backK051462 Modification to: Cercon BaseDentsply Intl. · 2005
- This deviceK112152 Cercon HTDentsply International, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK241557 Cercon® yo MLDentsply Sirona · 2024
- Descendant · cites it directly · 0 of its ownK152247 ATLANTIS CrownDentsply International, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK130184 ZenoluxWieland Dental + Technik GmbH & Co. KG · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013230 | Cercon Base | Degussa - Ney Dental, Inc. | 2001 | — |
| −1 | K051462 | Modification to: Cercon Base | Dentsply Intl. | 2005 | — |
| 0 (this device) | K112152 | Cercon HT | Dentsply International, Inc. | 2011 | — |
| +1 | K241557 | Cercon® yo ML | Dentsply Sirona | 2024 | — |
| +1 | K152247 | ATLANTIS Crown | Dentsply International, Inc. | 2016 | — |
| +1 | K130184 | Zenolux | Wieland Dental + Technik GmbH & Co. KG | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 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 15.3 · 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 |
|---|---|---|---|
| * | K013230 | Cercon BaseSummary page 1…2 1CFR 872.6600 * Device Class: 11 * Product Code: EIH 3. Predicate Device: Cercon Base, K0 13230 and K05 1462 4. Description of Device: Cercon ht is a ceramic composed of partially sintered yttria stabilized zir… | 2001 |
| * | K051462 | Modification to: Cercon BaseSummary page 1…2 1CFR 872.6600 * Device Class: 11 * Product Code: EIH 3. Predicate Device: Cercon Base, K0 13230 and K05 1462 4. Description of Device: Cercon ht is a ceramic composed of partially sintered yttria stabilized zirconia… | 2005 |
What descends from it? (3)
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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241557 (Dentsply Sirona, 2024) has gone furthest, with 0 descendants of its own.
- 14 other devices also cite its predicate K013230.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Cercon® ht is indicated in the anterior and posterior segments for:
* crowns
* telescopic primary crowns
* multi-unit bridges (with no more than two pontics between abutment crowns)
Cercon® ht can be used as a substructure (framework) which is then veneered with a dental veneering ceramic or can be used for full-contour application (without veneering) as well. In the case of telescopic primary crowns' the substructure is not veneered.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112152 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112152: Cercon HT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112152
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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