510(k) · Cleared
ClearedSysnpar Porcelain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeneric/Pentron, Inc. · ELL Teeth, Porcelain
Cleared on Mar 8, 1991 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Mar 8, 1991
- Review
- 43 days
- Class
- Class II
- Product code
- ELL
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
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 |
|---|---|---|---|---|---|
| 0 (this device) | K910303 | Sysnpar Porcelain | Jeneric/Pentron, Inc. | 1991 | — |
| +1 | K012231 | Avante Micro Crystal System | Jeneric/Pentron, Inc. | 2001 | — |
| +1 | K993249 | Opc Low Wear Opaque Porcelain | Jeneric/Pentron, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ELL? 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 ELL device
- #1 K240586 Additive Manufacturing Zirconia Customized…score 8.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
- Of its descendants, K012231 (Jeneric/Pentron, Inc., 2001) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ELL devicesELL Teeth, Porcelain: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ELL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ELL
Too few ELL 510(k)s in any year since 2007 to give a median.
Recalls per year · ELL
No recall names ELL since 2007.
Adverse event reports per year · ELL
1in 2020
MAUDE reports naming product code ELL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K910303 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910303: Sysnpar Porcelain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910303
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026