510(k) · Cleared
ClearedCompolglass Compoglass Sca
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar North America, Inc. · EBF Material, Tooth Shade, Resin
Cleared on May 25, 1995 after a 35-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- May 25, 1995
- Review
- 35 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK951836 Compolglass Compoglass ScaIvoclar North America, Inc. · 1995
- Descendant · cites it directly · 9 of its ownK962442 Hytac Aplitip/Hytac OsbEspe GmbH & Co. Kg. · 1996
- Descendant · 2 generations on · 5 of its ownK984246 Prompt L-PopEspe Dental AG · 1999
- Descendant · 2 generations on · 1 of its ownK992966 ReferenceEspe Dental AG · 1999
- Descendant · 3 generations on · 0 of its ownK210945 Ultra SEPReliance Orthodontic Products, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK071688 Reliance S.E.P.Reliance Orthodontic Products, Inc. · 2007
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K962442Hytac Aplitip/Hytac OsbEspe GmbH & Co. Kg. · 1996 · cites it directly9descendants
- K984246Prompt L-PopEspe Dental AG · 1999 · 2 generations on5descendants
- K992966ReferenceEspe Dental AG · 1999 · 2 generations on1descendant
- K210945Ultra SEPReliance Orthodontic Products, Inc. · 2021 · 3 generations on0descendants
- K071688Reliance S.E.P.Reliance Orthodontic Products, Inc. · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951836 | Compolglass Compoglass Sca | Ivoclar North America, Inc. | 1995 | — |
| +1 | K962442 | Hytac Aplitip/Hytac Osb | Espe GmbH & Co. Kg. | 1996 | — |
| +2 | K984246 | Prompt L-Pop | Espe Dental AG | 1999 | — |
| +2 | K992966 | Reference | Espe Dental AG | 1999 | — |
| +3 | K210945 | Ultra SEP | Reliance Orthodontic Products, Inc. | 2021 | — |
| +3 | K071688 | Reliance S.E.P. | Reliance Orthodontic Products, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 5 | 0 |
| 2007 | 1 | 0 |
| 2021 | 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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
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, K962442 (Espe GmbH & Co. Kg., 1996) has gone furthest, with 9 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K951836 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951836: Compolglass Compoglass Sca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951836
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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