510(k) · Cleared
ClearedBelleglashp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties, Inc. · EBG Crown And Bridge, Temporary, Resin
Cleared on Jan 2, 1996 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 23 later devices descend from it.
- Decided
- Jan 2, 1996
- Review
- 43 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 3 citing it directly.
- This deviceK955331 BelleglashpSybron Dental Specialties, Inc. · 1996
- Descendant · cites it directly · 18 of its ownK982164 EsteniaKuraray America, Inc. · 1998
- Descendant · 2 generations on · 17 of its ownK012707 EsteniaKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 15 of its ownK982259 Chroma Zone Color StainKuraray America, Inc. · 1998
- Descendant · 2 generations on · 14 of its ownK012737 Chroma Zone Color StainKuraray Medical, Inc. · 2001
- Descendant · 3 generations on · 12 of its ownK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K982164EsteniaKuraray America, Inc. · 1998 · cites it directly18descendants
- K012707EsteniaKuraray Medical, Inc. · 2001 · 2 generations on17descendants
- K982259Chroma Zone Color StainKuraray America, Inc. · 1998 · cites it directly15descendants
- K012737Chroma Zone Color StainKuraray Medical, Inc. · 2001 · 2 generations on14descendants
- K042929Estenia C&BKuraray Medical Kurashiki Plant · 2004 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955331 | Belleglashp | Sybron Dental Specialties, Inc. | 1996 | — |
| +1 | K982164 | Estenia | Kuraray America, Inc. | 1998 | — |
| +2 | K012707 | Estenia | Kuraray Medical, Inc. | 2001 | — |
| +1 | K982259 | Chroma Zone Color Stain | Kuraray America, Inc. | 1998 | — |
| +2 | K012737 | Chroma Zone Color Stain | Kuraray Medical, Inc. | 2001 | — |
| +3 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 3 | 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 EBG? 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 EBG device
- #1 K253380 “FLNT Base” and “FLNT Temp”score 12.4 · 6 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (23)
See all 233 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, K982164 (Kuraray America, Inc., 1998) has gone furthest, with 18 descendants of its own.
How does its category compare?
All EBG devicesEBG Crown And Bridge, Temporary, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBG
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBG
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBG
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBG
1in 2025
MAUDE reports naming product code EBG, 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 | 3 | 64 | 0 | 4 |
| 2008 | 9 | 83 | 0 | 4 |
| 2009 | 2 | — | 1 | 1 |
| 2010 | 5 | 103 | 0 | 1 |
| 2011 | 10 | 96 | 0 | 1 |
| 2012 | 5 | 90 | 0 | 5 |
| 2013 | 2 | — | 0 | 11 |
| 2014 | 3 | 114 | 0 | 23 |
| 2015 | 6 | 209 | 0 | 26 |
| 2016 | 4 | 163 | 0 | 8 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 4 | 202 | 0 | 0 |
| 2019 | 6 | 98 | 0 | 6 |
| 2020 | 14 | 194 | 1 | 2 |
| 2021 | 3 | 265 | 0 | 4 |
| 2022 | 3 | 73 | 0 | 2 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 5 | 144 | 0 | 0 |
| 2025 | 4 | 106 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K955331 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955331: Belleglashp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955331
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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