510(k) · Cleared
ClearedLuminesse Porcelain System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talladium, Inc. · EIH Powder, Porcelain
Cleared on Dec 17, 2014 as substantially equivalent to K040421 (Dentsply Intl., 2004) and 2 other predicates after a 258-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Dec 17, 2014
- Review
- 258 days
- Class
- Class II
- Product code
- EIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K944702 (1994). 7 ancestors in all, the oldest K900209 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK944702 Procera All-Ceramic PorcelainNobelpharma USA, Inc. · 1994
- 2 generations backK041312 Nobelrondo Dental Ceramic-AluminaNobel Biocare Uas, Inc. · 2004
- 1 generation backK043312 Nobelrondo Dental Ceramic - ZirconiaNobel Biocare USA, LLC · 2005
- This deviceK140848 Luminesse Porcelain SystemTalladium, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK182350 Dental CeramicBaot Biological Technology Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK163251 Life Essence Universal Porcelain SystemBlue Sky Bio · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944702 | Procera All-Ceramic Porcelain | Nobelpharma USA, Inc. | 1994 | — |
| −2 | K041312 | Nobelrondo Dental Ceramic-Alumina | Nobel Biocare Uas, Inc. | 2004 | — |
| −1 | K043312 | Nobelrondo Dental Ceramic - Zirconia | Nobel Biocare USA, LLC | 2005 | — |
| 0 (this device) | K140848 | Luminesse Porcelain System | Talladium, Inc. | 2014 | — |
| +1 | K182350 | Dental Ceramic | Baot Biological Technology Co., Ltd. | 2019 | — |
| +1 | K163251 | Life Essence Universal Porcelain System | Blue Sky Bio | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K040421 | Duceragold PorcelainsSummary page 4…mmon Name Porcelain powder for clinical use Predicate 510(k) Duceragold Porcelains (K040421), Willi Geller Creation Porcelain… | 2004 |
| * | K981490 | Willi Geller Creation PorcelainSummary page 4…orcelains (K040421), Willi Geller Creation Porcelain (K981490), NobelRondo Dental Ceramic – Zirconia (K043312) Product Code… | 1998 |
| * | K043312 | Nobelrondo Dental Ceramic - ZirconiaSummary page 4…lain (K981490), NobelRondo Dental Ceramic – Zirconia (K043312) Product Code EIH Regulation No. 872.6660… | 2005 |
What descends from it? (2)
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 20 years and passes through 4 companies; a new generation was cleared every 9.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K182350 (Baot Biological Technology Co., Ltd., 2019) has gone furthest, with 0 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. 2014, 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 Luminesse Porcelain System is dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140848: Luminesse Porcelain System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140848
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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