510(k) · Cleared
ClearedIncoris AL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · EIH Powder, Porcelain
Cleared on Sep 8, 2006 after an 11-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 189 later devices descend from it.
- Decided
- Sep 8, 2006
- Review
- 11 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
189 later devices descend from it, 3 citing it directly.
- This deviceK062506 Incoris ALSirona Dental Systems GmbH · 2006
- Descendant · cites it directly · 186 of its ownK072569 Metoxit Cam-BlanksMetoxit AG · 2007
- Descendant · 2 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 3 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
- Descendant · 3 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 4 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Showing 5 of 189 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 189 · See all- K072569Metoxit Cam-BlanksMetoxit AG · 2007 · cites it directly186descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 2 generations on165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 3 generations on129descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 3 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 4 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062506 | Incoris AL | Sirona Dental Systems GmbH | 2006 | — |
| +1 | K072569 | Metoxit Cam-Blanks | Metoxit AG | 2007 | — |
| +2 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +3 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
| +3 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 11 | 0 |
| 2016 | 6 | 0 |
| 2017 | 8 | 0 |
| 2018 | 12 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 0 |
| 2021 | 18 | 0 |
| 2022 | 15 | 0 |
| 2023 | 24 | 0 |
| 2024 | 27 | 0 |
| 2025 | 25 | 0 |
| 2026 | 12 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (189)
See all 1893 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?
- Of its descendants, K072569 (Metoxit AG, 2007) has gone furthest, with 186 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?
inCoris AL are indicated for use as a substructure for porcelain fused ceramic fixed dental restorations; for single unit anterior or posterior crowns and 3 unit anterior bridges.
Substructures of inCoris AL for CEREC are machined using the CEREC 2, CEREC 3 and inLab CAD/CAM systems.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062506: Incoris AL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062506
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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