510(k) · Cleared
ClearedResin for Temporary Crown & Bridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentis Co., Ltd. · EBG Crown And Bridge, Temporary, Resin
Cleared on Dec 7, 2018 as substantially equivalent to K102776 (Deltamed GmbH, 2011) after a 269-day review. Its family tree reaches back 2 generations to 2007. 4 later devices descend from it.
- Decided
- Dec 7, 2018
- Review
- 269 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070991 (2007). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK070991 Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102…Vita · 2007
- 1 generation backK102776 Extra-Oral, Additive Computer Aided Manufacture and Curing SystemDeltamed GmbH · 2011
- This deviceK180657 Resin for Temporary Crown & BridgeDentis Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK200273 FREEPRINT tempDetax GmbH & Co. KG · 2020
- Descendant · 2 generations on · 0 of its ownK213643 UltraPrint-Dental Temp C&B UVGuangzhou Heygears IMC., Inc. · 2022
- Descendant · cites it directly · 0 of its ownK210817 C&B 5.0 HybridArum Dentistry Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK193113 GC Temp PrintGC America, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K200273FREEPRINT tempDetax GmbH & Co. KG · 2020 · cites it directly1descendant
- K213643UltraPrint-Dental Temp C&B UVGuangzhou Heygears IMC., Inc. · 2022 · 2 generations on0descendants
- K210817C&B 5.0 HybridArum Dentistry Co., Ltd. · 2021 · cites it directly0descendants
- K193113GC Temp PrintGC America, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070991 | Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110… | Vita | 2007 | — |
| −1 | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing System | Deltamed GmbH | 2011 | — |
| 0 (this device) | K180657 | Resin for Temporary Crown & Bridge | Dentis Co., Ltd. | 2018 | — |
| +1 | K200273 | FREEPRINT temp | Detax GmbH & Co. KG | 2020 | — |
| +2 | K213643 | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. | 2022 | — |
| +1 | K210817 | C&B 5.0 Hybrid | Arum Dentistry Co., Ltd. | 2021 | — |
| +1 | K193113 | GC Temp Print | GC America, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 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? (1)
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 |
|---|---|---|---|
| * | K102776 | Extra-Oral, Additive Computer Aided Manufacture and Curing SystemSummary page 4…872.3770 Regulation Number DeltaMed GMBH Predicate Device e-Dent Temporary Resin and Extra-Oral Curing System (K102776, Feb 18, 2011 - Primary Predicate) The Resin for Temporary Crown & Bridge is made by Methacrylate… | 2011 |
What descends from it? (4)
3 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K200273 (Detax GmbH & Co. KG, 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K102776.
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. 2018, 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?
Resin for Temporary Crown & Bridge is indicated for the fabrication of temporary dental restorations in conjunction with
extra-oral curing light equipment. Duration is less than 30 days in oral environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180657 · printed Nov 3, 2026
Cite this page
510(k) Report. “K180657: Resin for Temporary Crown & Bridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K180657
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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