510(k) · Cleared
ClearedConnect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties, Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on Oct 30, 1995 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Oct 30, 1995
- Review
- 19 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 2 citing it directly.
- This deviceK954689 ConnectSybron Dental Specialties, Inc. · 1995
- Descendant · cites it directly · 12 of its ownK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
- Descendant · 2 generations on · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
- Descendant · 3 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007
- Descendant · 2 generations on · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K042929Estenia C&BKuraray Medical Kurashiki Plant · 2004 · cites it directly12descendants
- K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · 2 generations on6descendants
- K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · 3 generations on4descendants
- K063595Clearfil Majesty PosteriorKuraray America, Inc. · 2007 · 2 generations on4descendants
- K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954689 | Connect | Sybron Dental Specialties, Inc. | 1995 | — |
| +1 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
| +2 | K111982 | Clearfil DC Core Plus | Kuraray America, Inc. | 2011 | — |
| +3 | K142625 | PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value… | Kuraray Noritake Dental, Inc. | 2015 | — |
| +2 | K063595 | Clearfil Majesty Posterior | Kuraray America, Inc. | 2007 | — |
| +2 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory… | Kuraray Noritake Dental, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 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 EBI? 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 EBI device
- #1 K250617 Apex Flexscore 18.3 · 1 generation · 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? (14)
See all 142 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, K042929 (Kuraray Medical Kurashiki Plant, 2004) has gone furthest, with 12 descendants of its own.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, 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 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
https://510kreport.com/device/K954689 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954689: Connect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954689
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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