510(k) · Cleared
ClearedNobelrondo Dental Ceramic - Zirconia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nobel Biocare USA, LLC · EIH Powder, Porcelain
Cleared on Feb 1, 2005 as substantially equivalent to K041312 (Nobel Biocare Uas, Inc., 2004) after a 62-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Feb 1, 2005
- Review
- 62 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944702 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK944702 Procera All-Ceramic PorcelainNobelpharma USA, Inc. · 1994
- 1 generation backK041312 Nobelrondo Dental Ceramic-AluminaNobel Biocare Uas, Inc. · 2004
- This deviceK043312 Nobelrondo Dental Ceramic - ZirconiaNobel Biocare USA, LLC · 2005
- Descendant · cites it directly · 2 of its ownK140848 Luminesse Porcelain SystemTalladium, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK182350 Dental CeramicBaot Biological Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK163251 Life Essence Universal Porcelain SystemBlue Sky Bio · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944702 | Procera All-Ceramic Porcelain | Nobelpharma USA, Inc. | 1994 | — |
| −1 | K041312 | Nobelrondo Dental Ceramic-Alumina | Nobel Biocare Uas, Inc. | 2004 | — |
| 0 (this device) | K043312 | Nobelrondo Dental Ceramic - Zirconia | Nobel Biocare USA, LLC | 2005 | — |
| +1 | K140848 | Luminesse Porcelain System | Talladium, Inc. | 2014 | — |
| +2 | K182350 | Dental Ceramic | Baot Biological Technology Co., Ltd. | 2019 | — |
| +2 | K163251 | Life Essence Universal Porcelain System | Blue Sky Bio | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K041312 | Nobelrondo Dental Ceramic-AluminaSummary page 1…r Proprietary or Model Name: NobelRondo Dental Ceramic - Zirconia Legally Marketed Device(s): NobelRondo Dental Ceramic- Alumina (K041312) Device Description: NobelRondo Dental Ceramic - Zirconia is dental porcelain intended for use in the construction of zirconiu… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140848 | Luminesse Porcelain System | 2014 | 2 |
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 11 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K140848 (Talladium, Inc., 2014) has gone furthest, with 2 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?
NobelRondo Dental Ceramic Zirconia is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from zirconia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043312 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043312: Nobelrondo Dental Ceramic - Zirconia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043312
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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