510(k) · Cleared
ClearedProtemp 3 Garant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Espe AG Dental Products · EBG Crown And Bridge, Temporary, Resin
Cleared on Nov 21, 2003 as substantially equivalent to K002364 (Espe Dental AG, 2000) and 1 other predicate after a 57-day review. Its family tree reaches back 1 generation to 2000. 46 later devices descend from it.
- Decided
- Nov 21, 2003
- Review
- 57 days
- Class
- Class II
- Product code
- EBG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001114 (2000). 2 ancestors in all. 46 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK001114 3M Quik Temp Temporization Material3M Company · 2000
- This deviceK033022 Protemp 3 Garant3M Espe AG Dental Products · 2003
- Descendant · cites it directly · 37 of its ownK043043 Hermes Bond 23M Espe AG Dental Products · 2005
- Descendant · 2 generations on · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 3 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · 4 generations on · 8 of its ownK112118 DreambondBisco, Inc. · 2011
- Descendant · 5 generations on · 6 of its ownK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K043043Hermes Bond 23M Espe AG Dental Products · 2005 · cites it directly37descendants
- K071131UNO3M Espe AG Dental Products · 2007 · 2 generations on35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 3 generations on34descendants
- K112118DreambondBisco, Inc. · 2011 · 4 generations on8descendants
- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001114 | 3M Quik Temp Temporization Material | 3M Company | 2000 | — |
| 0 (this device) | K033022 | Protemp 3 Garant | 3M Espe AG Dental Products | 2003 | — |
| +1 | K043043 | Hermes Bond 2 | 3M Espe AG Dental Products | 2005 | — |
| +2 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +3 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +4 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
| +5 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (2)
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 |
|---|---|---|---|
| * | K002364 | Protemp HSummary page 2…Crown and Bridge Material Predicate Device: ProtempTMH by 3M ESPE, K 002364 3MTMQuik Temp Temporization Material, K 00 1 1 14 Description for the Premarket Notific… | 2000 |
| * | K001114 | 3M Quik Temp Temporization MaterialSummary page 2…Bridge Material Predicate Device: ProtempTMH by 3M ESPE, K 002364 3MTMQuik Temp Temporization Material, K 00 1 1 14 Description for the Premarket Notification Protemp 3 Garant is a temporary crown and bridge… | 2000 |
What descends from it? (46)
See all 464 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?
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 | — |
What is it indicated for?
Fabrication of temporary crowns, bridges, inlays, onlays and veneers.
Crown lining material for 3M ESPE Prefabricated Temporary Crowns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033022 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033022: Protemp 3 Garant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033022
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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