510(k) · Cleared
ClearedFinesse All-Ceramic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EIH Powder, Porcelain
Cleared on Sep 11, 1997 as substantially equivalent to K830955 (Dentsply Intl., 1983) after a 113-day review. Its family tree reaches back 1 generation to 1983. 100 later devices descend from it.
- Decided
- Sep 11, 1997
- Review
- 113 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K830955 (1983). 100 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- This deviceK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- Descendant · cites it directly · 93 of its ownK984201 DenzirDentronic AB · 1999
- Descendant · 2 generations on · 91 of its ownK023327 Cynovad ZirkonCynovad · 2002
- Descendant · 2 generations on · 80 of its ownK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- Descendant · 2 generations on · 76 of its ownK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- Descendant · 3 generations on · 43 of its ownK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 100 · See all- K984201DenzirDentronic AB · 1999 · cites it directly93descendants
- K023327Cynovad ZirkonCynovad · 2002 · 2 generations on91descendants
- K043472Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005 · 2 generations on80descendants
- K062695Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006 · 2 generations on76descendants
- K081850Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008 · 3 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| 0 (this device) | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| +1 | K984201 | Denzir | Dentronic AB | 1999 | — |
| +2 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| +2 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| +2 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| +3 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K830955 | Dental Ceramic for Fabrication of CrownSummary page 1…1997 TRADE OR PROPRIETARY NAME: FINESSE™ ALL-CERAMIC SYSTEM CLASSIFICATION NAME: Porcelain Powder for Clinical Use 872.6660 PREDICATE DEVICE: DICOR® Castable Ceramic K830955A DEVICE DESCRIPTION: The FINESSE™ALL-CERAMIC SYSTEM is a glass-ceramic material designed to be used with Finesse™ Low-Fusing Por… | 1983 |
What descends from it? (100)
See all 1004 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?
- Its one ancestor has no recall.
- Of its descendants, K984201 (Dentronic AB, 1999) has gone furthest, with 93 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?
Used only with FINESSE™ Low-Fusing Porcelain for the fabrication of dental restorations: for inlays, onlays, veneers, complete crowns on anterior teeth, and for single crowns on
selected posterior teeth.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971869 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971869: Finesse All-Ceramic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971869
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