510(k) · Cleared
ClearedDenzir
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentronic AB · EIH Powder, Porcelain
Cleared on Sep 29, 1999 as substantially equivalent to K973221 (Dentsply Intl., 1998) and 2 other predicates after a 309-day review. Its family tree reaches back 2 generations to 1983. 93 later devices descend from it.
- Decided
- Sep 29, 1999
- Review
- 309 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K830955 (1983). 6 ancestors in all. 93 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 1 generation backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- This deviceK984201 DenzirDentronic AB · 1999
- Descendant · cites it directly · 91 of its ownK023327 Cynovad ZirkonCynovad · 2002
- Descendant · cites it directly · 80 of its ownK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- Descendant · cites it directly · 76 of its ownK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- Descendant · 2 generations on · 43 of its ownK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- Descendant · 3 generations on · 41 of its ownK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
Showing 5 of 93 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 93 · See all- K023327Cynovad ZirkonCynovad · 2002 · cites it directly91descendants
- K043472Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005 · cites it directly80descendants
- K062695Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006 · cites it directly76descendants
- K081850Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008 · 2 generations on43descendants
- K093560Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010 · 3 generations on41descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −1 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| 0 (this device) | K984201 | Denzir | Dentronic AB | 1999 | — |
| +1 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| +1 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| +1 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| +2 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
| +3 | K093560 | Upcera Zirconia Blanks | Shenyang Upcera Co., Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 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 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K973221 | Composite 168 Restorative SystemSummary page 1…ablished as the basis of many different kinds of implants, mainly more demanding than is the mouth. Denzir™ is equivalent in use and properties to devices described in K-973221, K-971869, and K-943168. 4. This product has been tested for biocompatibility by methods accepted in the US. and… | 1998 |
| * | K971869 | Finesse All-Ceramic SystemSummary page 1…s the basis of many different kinds of implants, mainly more demanding than is the mouth. Denzir™ is equivalent in use and properties to devices described in K-973221, K-971869, and K-943168. 4. This product has been tested for biocompatibility by methods accepted in the US. and Europe. Th… | 1997 |
| * | K943168 | Clearfil AP-XSummary page 1…many different kinds of implants, mainly more demanding than is the mouth. Denzir™ is equivalent in use and properties to devices described in K-973221, K-971869, and K-943168. 4. This product has been tested for biocompatibility by methods accepted in the US. and Europe. The material mee… | 1994 |
What descends from it? (93)
See all 938 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 16 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K023327 (Cynovad, 2002) has gone furthest, with 91 descendants of its own.
- 4 other devices also cite its predicate K973221.
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?
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.
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/K984201 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984201: Denzir.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984201
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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