510(k) · Cleared
ClearedTempocem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmg USA, Inc. · EMB Zinc Oxide Eugenol
Cleared on Jun 10, 2011 as substantially equivalent to K970775 (Foremost Dental Mfg., Inc., 1997) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Jun 10, 2011
- Review
- 84 days
- Class
- Class I
- Product code
- EMB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K982590 (1998). 3 ancestors in all, the oldest K970775 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK982590 Tempbond Clear-2Sybron Dental Specialties, Inc. · 1998 · Recalled
- 1 generation backK091735 DC Provi Cem Esthetic, Esthetic Multi F, ImplantS & C Polymer GmbH · 2009
- This deviceK110759 TempocemDmg USA, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK142446 Fixtemp CementExacta Dental Direct, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142446Fixtemp CementExacta Dental Direct, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982590 | Tempbond Clear-2 | Sybron Dental Specialties, Inc. | 1998 | 2 |
| −1 | K091735 | DC Provi Cem Esthetic, Esthetic Multi F, Implant | S & C Polymer GmbH | 2009 | — |
| 0 (this device) | K110759 | Tempocem | Dmg USA, Inc. | 2011 | — |
| +1 | K142446 | Fixtemp Cement | Exacta Dental Direct, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 EMB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K970775 | Tempo Cem (Multiple)Summary page 1…AmiWC -i I. J 102I1.0 02A,6-, N W ki Tempoem K970775 (Foremost Dental, Inc) S&C Provi Gemn Esthetic IK091735 (S&C Polymer GmnbI-) Safety and Performance… | 1997 |
| * | K091735 | DC Provi Cem Esthetic, Esthetic Multi F, ImplantSummary page 1…I1.0 02A,6-, N W ki Tempoem K970775 (Foremost Dental, Inc) S&C Provi Gemn Esthetic IK091735 (S&C Polymer GmnbI-) Safety and Performance: This submission is an Abbreviated 510(k) as described In FDAs guidance document en… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142446 | Fixtemp Cement | 2015 | 0 |
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 13 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K142446 (Exacta Dental Direct, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EMB devicesEMB Zinc Oxide Eugenol: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · EMB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · EMB
Too few EMB 510(k)s in any year since 2007 to give a median.
Recalls per year · EMB
No recall names EMB since 2007.
Adverse event reports per year · EMB
3in 2025
MAUDE reports naming product code EMB, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
TempoCem is a dental luting agent indicated for
* temporary cementation of provisional crowns and bridges
* cementing of semi-permanent implants
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110759: Tempocem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110759
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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