510(k) · Cleared
ClearedKDF Zirconia Disc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Denken-Highdental Co., Ltd. · EIH Powder, Porcelain
Cleared on Jul 14, 2022 as substantially equivalent to K171585 (Dentalmax Co., Ltd., 2018) and 1 other predicate after a 59-day review. Its family tree reaches back 11 generations to 1983.
- Decided
- Jul 14, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K830955 (1983). 31 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 7 generations between
- 3 generations backK111291 Aidite Zirconia Dental CeramicsQinhuangdao Aidite High-Technical Ceramics Co, Ltd. · 2011
- 2 generations backK182068 Erran Dental ZirconiaHangzhou Erran Technology Co., Ltd. · 2018
- 1 generation backK192262 Dental Zirconia BlocksDe Corematrix Co., Ltd. · 2020
- This deviceK221429 KDF Zirconia DiscDenken-Highdental Co., Ltd. · 2022
Show all 11 generations
- Root · 11 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 10 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 9 generations backK984201 DenzirDentronic AB · 1999
- 8 generations backK023327 Cynovad ZirkonCynovad · 2002
- 7 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 6 generations backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- 5 generations backK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- 4 generations backK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
- 3 generations backK111291 Aidite Zirconia Dental CeramicsQinhuangdao Aidite High-Technical Ceramics Co, Ltd. · 2011
- 2 generations backK182068 Erran Dental ZirconiaHangzhou Erran Technology Co., Ltd. · 2018
- 1 generation backK192262 Dental Zirconia BlocksDe Corematrix Co., Ltd. · 2020
- This deviceK221429 KDF Zirconia DiscDenken-Highdental Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −10 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −9 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −8 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −7 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −6 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| −5 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
| −4 | K093560 | Upcera Zirconia Blanks | Shenyang Upcera Co., Ltd. | 2010 | — |
| −3 | K111291 | Aidite Zirconia Dental Ceramics | Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. | 2011 | — |
| −2 | K182068 | Erran Dental Zirconia | Hangzhou Erran Technology Co., Ltd. | 2018 | — |
| −1 | K192262 | Dental Zirconia Blocks | De Corematrix Co., Ltd. | 2020 | — |
| 0 (this device) | K221429 | KDF Zirconia Disc | Denken-Highdental Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 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 15.2 · 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? (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 |
|---|---|---|---|
| * | K171585 | LUXEN Zr, LUXEN SmileSummary page 5…II Product Code: EIH Panel: Dental Predicate Device Primary Predicate Device: LUXEN Zr, LUXEN Smile (K171585) by DENTALMAX Co., Ltd. Secondary Predicate Device: Dental Zirconia Blocks (K192262) by De Corematrix Co., Ltd. Device Desc… | 2018 |
| * | K192262 | Dental Zirconia BlocksSummary page 5…Dental Predicate Device Primary Predicate Device: LUXEN Zr, LUXEN Smile (K171585) by DENTALMAX Co., Ltd. Secondary Predicate Device: Dental Zirconia Blocks (K192262) by De Corematrix Co., Ltd. Device Description KDF Zirconia Disc is used for custom made dental restorations using a CAD/CAM… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 11 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 31 ancestors has a recall of any class.
- 3 other devices also cite its predicate K171585.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
KDF Zirconia Disc is indicated for the production of dental ceramic restorations, specifically inlays, onlays, veneers, artificial teeth, crowns and bridges, which is manufactured by CAD / CAM processing. The application includes both anterior teeth and posterior teeth areas. All blocks are processed by a dental laboratory or dental technician.
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/K221429 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221429: KDF Zirconia Disc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221429
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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