510(k) · Cleared
ClearedVita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model VX60 XXXX, VX61 XXXX, VX62 XXXX; Vita VM 9, Model NX98
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vident · EIH Powder, Porcelain
Cleared on Apr 27, 2006 after a 65-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Apr 27, 2006
- Review
- 65 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK060441 Vita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model…Vident · 2006
- Descendant · cites it directly · 5 of its ownK151731 Rainbow Paste StainGenoss · 2016
- Descendant · 2 generations on · 3 of its ownK181167 Upcera Glaze Paste, Glaze Powder, and Glaze LiquidLiaoning Upcera Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK232676 Dental Porcelain PowderChengdu Besmile Medical Technology Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK260067 Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK250025 Porcelain Powder (Enamel/…Aidite (Qinhuangdao) Technology Co., Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K151731Rainbow Paste StainGenoss · 2016 · cites it directly5descendants
- K181167Upcera Glaze Paste, Glaze Powder, and Glaze LiquidLiaoning Upcera Co., Ltd. · 2018 · 2 generations on3descendants
- K232676Dental Porcelain PowderChengdu Besmile Medical Technology Co., Ltd. · 2024 · cites it directly1descendant
- K260067Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation · 2026 · 3 generations on0descendants
- K250025Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )Aidite (Qinhuangdao) Technology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060441 | Vita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model VX60 XXXX… | Vident | 2006 | — |
| +1 | K151731 | Rainbow Paste Stain | Genoss | 2016 | — |
| +2 | K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | Liaoning Upcera Co., Ltd. | 2018 | — |
| +1 | K232676 | Dental Porcelain Powder | Chengdu Besmile Medical Technology Co., Ltd. | 2024 | — |
| +3 | K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | 2026 | — |
| +2 | K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
3 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?
- Of its descendants, K151731 (Genoss, 2016) has gone furthest, with 5 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?
Vita VM® porcelains are indicated for use as a veneering material for fixed prosthesis in crowns, bridges, and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to a ceramic or metal substructure into the shape of a dental crown.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K060441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060441: Vita VM 7, Model NX77 XXXX, NX78XXXX, NX79 XXXX; Vita VM 8, Model VX60 XXXX, VX61 XXXX, VX62 XXXX; Vita VM 9, Model NX98.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060441
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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