510(k) · Cleared
ClearedPentamix 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · EFD Amalgamator, Dental, Ac-Powered
Cleared on Jul 26, 1999 as substantially equivalent to K891064 (Espe GmbH (Us), 1989) after a 49-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jul 26, 1999
- Review
- 49 days
- Class
- Class I
- Product code
- EFD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891064 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK891064 Espe CapmixEspe GmbH (Us) · 1989
- This deviceK991913 Pentamix 2Espe Dental AG · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891064 | Espe Capmix | Espe GmbH (Us) | 1989 | — |
| 0 (this device) | K991913 | Pentamix 2 | Espe Dental AG | 1999 | — |
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 EFD? 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? (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 |
|---|---|---|---|
| * | K891064 | Espe CapmixSummary page 1…ator, Dental, AC-Powered Common Name:..........cccovvvireiiccnennenn. Automatic mixing device for ESPE PENTA impression materials Predicate Device CAPMIX® BY ESPE ... K 891064 Description for the Premarket Notification ESPE’s new mixing device for impression materials, PENTAMIX® 2, is comparable and su… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All EFD devicesEFD Amalgamator, Dental, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFD
FDA has decided no EFD device since 2007.
Median 510(k) review, days · EFD
Too few EFD 510(k)s in any year since 2007 to give a median.
Recalls per year · EFD
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFD
1in 2025
MAUDE reports naming product code EFD, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Automatic mixing, dosing and dispensing system for ESPE’s PENTA impression and bite registration materials:
IMPREGUM® PENTA
PERMADYNE® PENTA H
PERMADYNE® PENTA L
RAMITEC® PENTA
DIMENSION® PENTA H
DIMENSION® PENTA H QUICK
DIMENSION® PENTA L
POSITION® PENTA
POSITION® PENTA QUICK
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991913 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991913: Pentamix 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991913
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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