510(k) · Cleared
ClearedNissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nissin-Metec China Co., Ltd. · EIH Powder, Porcelain
Cleared on Jul 27, 2016 as substantially equivalent to K141724 (Liaoning Upcera Co., Ltd., 2014) after a 169-day review. Its family tree reaches back 9 generations to 1983. 6 later devices descend from it.
- Decided
- Jul 27, 2016
- Review
- 169 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. 6 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 deviceK160367 Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankNissin-Metec China Co., Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK180252 Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded BlankCrown Porcelain Dental Technology Co., Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK190112 Non-Sterile Zirconia BlockFine Advanced Compound Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK223253 Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Arum Dentistry Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK250063 ARENA Star, Galaxy StarArum Dentistry Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK201492 Non-Sterile Zirconia BlockBioden Co., Ltd. · 2021
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 deviceK160367 Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankNissin-Metec China Co., Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K180252Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded BlankCrown Porcelain Dental Technology Co., Ltd. · 2018 · cites it directly4descendants
- K190112Non-Sterile Zirconia BlockFine Advanced Compound Co., Ltd. · 2019 · 2 generations on3descendants
- K223253Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)Arum Dentistry Co., Ltd. · 2023 · 3 generations on1descendant
- K250063ARENA Star, Galaxy StarArum Dentistry Co., Ltd. · 2025 · 4 generations on0descendants
- K201492Non-Sterile Zirconia BlockBioden Co., Ltd. · 2021 · 3 generations on0descendants
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) | K160367 | Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Nissin-Metec China Co., Ltd. | 2016 | — |
| +1 | K180252 | Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank | Crown Porcelain Dental Technology Co., Ltd. | 2018 | — |
| +2 | K190112 | Non-Sterile Zirconia Block | Fine Advanced Compound Co., Ltd. | 2019 | — |
| +3 | K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | Arum Dentistry Co., Ltd. | 2023 | — |
| +4 | K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | 2025 | — |
| +3 | K201492 | Non-Sterile Zirconia Block | Bioden Co., Ltd. | 2021 | — |
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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (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 5…and Discs). Furthermore, each specification is available in twenty two (22) color configurations. 5. Identification of Predicate Device(s) 510(k) Number: K141724 Product Name: Upcera Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Manufacturer: Liaoning Upcera Co., Ltd… | 2014 |
What descends from it? (6)
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 33 years and passes through 9 companies; a new generation was cleared every 2.0 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K180252 (Crown Porcelain Dental Technology Co., Ltd., 2018) has gone furthest, with 4 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. 2016, 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?
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160367: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160367
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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