510(k) · Cleared
ClearedPerfit FS Dental Zirconia Fully Sintered Block
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vatech Acucera, Inc. · EIH Powder, Porcelain
Cleared on Jun 24, 2021 as substantially equivalent to K141724 (Liaoning Upcera Co., Ltd., 2014) after a 198-day review. Its family tree reaches back 9 generations to 1983. 4 later devices descend from it.
- Decided
- Jun 24, 2021
- Review
- 198 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K830955 (1983). 18 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 5 generations between
- 3 generations backK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- 2 generations backK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
- 1 generation backK141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd. · 2014
- This deviceK203590 Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK220816 BruxZir NOWPrismatik Dentalcraft, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK252446 BruxZir® NOWPrismatik Dentalcraft, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK250223 BruxZir® Esthetic NOWPrismatik Dentalcraft, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK222686 Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc. · 2022
Show all 9 generations
- Root · 9 generations backK830955 Dental Ceramic for Fabrication of CrownDentsply Intl. · 1983
- 8 generations backK971869 Finesse All-Ceramic SystemDentsply Intl. · 1997
- 7 generations backK984201 DenzirDentronic AB · 1999
- 6 generations backK023327 Cynovad ZirkonCynovad · 2002
- 5 generations backK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- 4 generations backK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- 3 generations backK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
- 2 generations backK093560 Upcera Zirconia BlanksShenyang Upcera Co., Ltd. · 2010
- 1 generation backK141724 Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankLiaoning Upcera Co., Ltd. · 2014
- This deviceK203590 Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K220816BruxZir NOWPrismatik Dentalcraft, Inc. · 2022 · cites it directly2descendants
- K252446BruxZir® NOWPrismatik Dentalcraft, Inc. · 2025 · 2 generations on0descendants
- K250223BruxZir® Esthetic NOWPrismatik Dentalcraft, Inc. · 2025 · 2 generations on0descendants
- K222686Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K830955 | Dental Ceramic for Fabrication of Crown | Dentsply Intl. | 1983 | — |
| −8 | K971869 | Finesse All-Ceramic System | Dentsply Intl. | 1997 | — |
| −7 | K984201 | Denzir | Dentronic AB | 1999 | — |
| −6 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| −5 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| −4 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| −3 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
| −2 | K093560 | Upcera Zirconia Blanks | Shenyang Upcera Co., Ltd. | 2010 | — |
| −1 | K141724 | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 2014 | — |
| 0 (this device) | K203590 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | 2021 | — |
| +1 | K220816 | BruxZir NOW | Prismatik Dentalcraft, Inc. | 2022 | — |
| +2 | K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | 2025 | — |
| +2 | K250223 | BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. | 2025 | — |
| +1 | K222686 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | 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 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K141724 | Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankSummary page 4…Product Code EIH 3. Predicated or legally marketed devices which are substantially equivalent Predicated device: K141724, “Upcera Dental Zirconia Blank and Dental Zirconia Pre- Shaded Blank”, manufactured by “Liaoning Upcera”… | 2014 |
| † | K203499 | Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank | 2021 |
What descends from it? (4)
2 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 38 years and passes through 9 companies; a new generation was cleared every 2.1 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K220816 (Prismatik Dentalcraft, Inc., 2022) has gone furthest, with 2 descendants of its own.
- 14 other devices also cite its predicate K141724.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Perfit FS Dental Zirconia Fully Sintered Block is used for dental restorations using different CAD / CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203590 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203590: Perfit FS Dental Zirconia Fully Sintered Block.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203590
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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