510(k) · Cleared
ClearedTelio Cad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ivoclar Vivadent, Inc. · EBG Crown And Bridge, Temporary, Resin
Cleared on Mar 10, 2010 after a 98-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Mar 10, 2010
- Review
- 98 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK093708 Telio CadIvoclar Vivadent, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK113739 Simplant Immediate Smile Dental Care SystemMaterialise Dental NV · 2012
- Descendant · cites it directly · 2 of its ownK172281 PuRE PMMA DiscQuest Dental USA Corp. · 2017
- Descendant · 2 generations on · 2 of its ownK170849 SIMPLANT GuideDentsply Sirona · 2017
- Descendant · cites it directly · 1 of its ownK151564 Telio CAD Abutment SolutionsIvoclar Vivadent, AG · 2015
- Descendant · 2 generations on · 0 of its ownK261456 Ruthinium DiscDental Manufacturing S.p.A. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K113739Simplant Immediate Smile Dental Care SystemMaterialise Dental NV · 2012 · cites it directly3descendants
- K172281PuRE PMMA DiscQuest Dental USA Corp. · 2017 · cites it directly2descendants
- K170849SIMPLANT GuideDentsply Sirona · 2017 · 2 generations on2descendants
- K151564Telio CAD Abutment SolutionsIvoclar Vivadent, AG · 2015 · cites it directly1descendant
- K261456Ruthinium DiscDental Manufacturing S.p.A. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093708 | Telio Cad | Ivoclar Vivadent, Inc. | 2010 | — |
| +1 | K113739 | Simplant Immediate Smile Dental Care System | Materialise Dental NV | 2012 | — |
| +1 | K172281 | PuRE PMMA Disc | Quest Dental USA Corp. | 2017 | — |
| +2 | K170849 | SIMPLANT Guide | Dentsply Sirona | 2017 | — |
| +1 | K151564 | Telio CAD Abutment Solutions | Ivoclar Vivadent, AG | 2015 | — |
| +2 | K261456 | Ruthinium Disc | Dental Manufacturing S.p.A. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 115 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, K113739 (Materialise Dental NV, 2012) has gone furthest, with 3 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. 2010, this device’s year, is highlighted.
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 | — |
What is it indicated for?
For the fabrication of temporary crowns and bridges using the CAD/CAM technology until the permanent restoration can be delivered.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093708 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093708: Telio Cad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093708
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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