510(k) · Cleared
ClearedDental Ceramic for Fabrication of Crown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EIH Powder, Porcelain
Cleared on May 9, 1983 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 101 later devices descend from it.
- Decided
- May 9, 1983
- Review
- 45 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
101 later devices descend from it, 1 citing it directly.
- This deviceK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- Descendant · cites it directly · 100 of its ownK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- Descendant · 2 generations on · 93 of its ownK984201 DenzirDentronic AB · 1999
- Descendant · 3 generations on · 91 of its ownK023327 Cynovad ZirkonCynovad · 2002
- Descendant · 3 generations on · 80 of its ownK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- Descendant · 3 generations on · 76 of its ownK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 101 · See all- K971869Finesse All-Ceramic SystemDentsply Intl. · 1997 · cites it directly100descendants
- K984201DenzirDentronic AB · 1999 · 2 generations on93descendants
- K023327Cynovad ZirkonCynovad · 2002 · 3 generations on91descendants
- K043472Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005 · 3 generations on80descendants
- K062695Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006 · 3 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| +1 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| +2 | K984201 | Denzir | Dentronic AB | 1999 | — |
| +3 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| +3 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| +3 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (101)
See all 1011 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971869 | Finesse All-Ceramic System | 1997 | 100 |
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, K971869 (Dentsply Intl., 1997) has gone furthest, with 100 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 | — |
https://510kreport.com/device/K830955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K830955: Dental Ceramic for Fabrication of Crown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830955
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026