510(k) · Cleared
ClearedStela Capsule System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sdi Limited · EBF Material, Tooth Shade, Resin
Cleared on Oct 28, 2022 as substantially equivalent to K053040 (Coltene/Whaledent AG, 2005) and 3 other predicates after a 63-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Oct 28, 2022
- Review
- 63 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K900510 (1990). 39 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- Root · 7 generations backK900510 Pertac-HybridEspe GmbH (Us) · 1990
- 6 generations backK962440 Pertac II/Pertac II AplitipEspe GmbH & Co. Kg. · 1996
- 5 generations backK974458 Compolute AplicapEspe Dental-Medizin GmbH & Co.Kg. · 1998
- 4 generations backK020256 Unicem3M Espe AG Dental Products · 2002
- 3 generations backK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- 2 generations backK071131 UNO3M Espe AG Dental Products · 2007
- 1 generation backK110302 Adhesive Exl-7593M Espe AG · 2011
- This deviceK222583 Stela Capsule SystemSdi Limited · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K900510 | Pertac-Hybrid | Espe GmbH (Us) | 1990 | — |
| −6 | K962440 | Pertac II/Pertac II Aplitip | Espe GmbH & Co. Kg. | 1996 | — |
| −5 | K974458 | Compolute Aplicap | Espe Dental-Medizin GmbH & Co.Kg. | 1998 | — |
| −4 | K020256 | Unicem | 3M Espe AG Dental Products | 2002 | — |
| −3 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| −2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| −1 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| 0 (this device) | K222583 | Stela Capsule System | Sdi Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K053040 | Paracem Universal DCSummary page 5…Name: Scotchbond Universal Adhesive2 Manufacturer: Coltene Manufacturer: 3M ESPE 510(k) Number: K053040 510(k) Number: K110302 Stela Capsule Name: Fill-Up! Name: Filtek Supreme Ultra Universal… | 2005 |
| * | K110302 | Adhesive Exl-759Summary page 5…niversal Adhesive2 Manufacturer: Coltene Manufacturer: 3M ESPE 510(k) Number: K053040 510(k) Number: K110302 Stela Capsule Name: Fill-Up! Name: Filtek Supreme Ultra Universal Manufactur… | 2011 |
| * | K150218 | Fill-Up!Summary page 5…ll-Up! Name: Filtek Supreme Ultra Universal Manufacturer: Coltene Restorative 510(k) Number: K150218 Manufacturer: 3M ESPE 510(k) Number: K083610 1 ParaBond was o… | 2015 |
| * | K083610 | Filtek Supreme Ultra Universal RestorativeSummary page 5…Restorative 510(k) Number: K150218 Manufacturer: 3M ESPE 510(k) Number: K083610 1 ParaBond was originally cleared in ParaCem Universal DC 510(k) based on the National Library of Medicine GUDID database not… | 2008 |
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?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 39 ancestors has a recall of any class.
- 3 other devices also cite its predicate K053040.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
Stela Primer:
- Dentin and enamel bonding
Stela Capsule
- Direct Class I, 11, Il and V cavities. Ideally Class I and 11
- Base or liner
- Core build-ups.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222583: Stela Capsule System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222583
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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