510(k) · Cleared
ClearedVITA Ambria
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vita Zahnfabrik GmbH H Rauter & CO · EIH Powder, Porcelain
Cleared on May 14, 2020 as substantially equivalent to K050362 (Vident, 2005) after a 155-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- May 14, 2020
- Review
- 155 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050362 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK050362 Vita PM 7 (20 Gram Bottles), Vita PM 7 (50 Gram Bottles)Vident · 2005
- This deviceK193436 VITA AmbriaVita Zahnfabrik GmbH H Rauter & CO · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050362 | Vita PM 7 (20 Gram Bottles), Vita PM 7 (50 Gram Bottles) | Vident | 2005 | — |
| 0 (this device) | K193436 | VITA Ambria | Vita Zahnfabrik GmbH H Rauter & CO | 2020 | — |
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 |
|---|---|---|---|
| * | K050362 | Vita PM 7 (20 Gram Bottles), Vita PM 7 (50 Gram Bottles)Summary page 5…EIH K193436 2 Predicate Devices VITA PM7; PM9 - K050362 – Primary Predicate Device Device Description VITA Ambria® VITA AMBRIA are zirconia-reinforced lithium silicate press pellets f… | 2005 |
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?
- Its one ancestor has no recall.
How does its category compare?
All EIH devicesEIH Powder, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
VITA AMBRIA are zirconia-reinforced lithium silicate press pellets for the fabrication of restorations in the press technique.
Indications
•Occlusal veneers (table tops), veneers
•Inlays, onlays, partial crowns
•Crowns in the anterior and posterior areas
•3-unit anterior bridges up to the second premolar
•Single tooth restorations as implant suprastructures for anterior and posterior teeth
•3-unit bridges as implant suprastructures up to the second premolar
•Single tooth mesostructures in the anterior and posterior areas
•Abutment crowns in the anterior and posterior areas
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193436 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193436: VITA Ambria.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193436
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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