510(k) · Cleared
ClearedPulpdent Endoprep II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corp. · EKL Point, Silver, Endodontic
Cleared on Apr 23, 1996 as substantially equivalent to K950365 (Union Broach, Div. Moyco Industries, Inc., 1995) and 2 other predicates after a 35-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Apr 23, 1996
- Review
- 35 days
- Class
- Class I
- Product code
- EKL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K896663 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK896663 Endo-PrepPulpdent Corp. · 1990
- This deviceK961089 Pulpdent Endoprep IIPulpdent Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896663 | Endo-Prep | Pulpdent Corp. | 1990 | — |
| 0 (this device) | K961089 | Pulpdent Endoprep II | Pulpdent Corp. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 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 EKL? 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? (7)
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 |
|---|---|---|---|
| * | K950365 | Moyco-EdtaSummary page 2…adent File-Eze K934415 ethylendiaminetetraacetic |Premier RC Prep Pre-amendment acid dihydrate (EDTA) Roth REDTA Chelating |Pre-amendment Agent Union Broach MoycoEDTA |K950365 Pulpdent Endo-Prep K896663 Pulpdent EDTA K932791 Preparations Buffered water | Thin and thick formula Ultradent File-Eze K934415… | 1995 |
| * | K896663 | Endo-PrepSummary page 2…lendiaminetetraacetic |Premier RC Prep Pre-amendment acid dihydrate (EDTA) Roth REDTA Chelating |Pre-amendment Agent Union Broach MoycoEDTA |K950365 Pulpdent Endo-Prep K896663 Pulpdent EDTA K932791 Preparations Buffered water | Thin and thick formula Ultradent File-Eze K934415 soluble base Premier RC Pre… | 1990 |
| * | K932791 | Pulpdent Edta PreparationsSummary page 2…|Premier RC Prep Pre-amendment acid dihydrate (EDTA) Roth REDTA Chelating |Pre-amendment Agent Union Broach MoycoEDTA |K950365 Pulpdent Endo-Prep K896663 Pulpdent EDTA K932791 Preparations Buffered water | Thin and thick formula Ultradent File-Eze K934415 soluble base Premier RC Prep Pre-amendment Roth R… | 1993 |
| * | — | Ultradent File-Eze Named without a submission number | |
| * | — | Premier RC Prep Named without a submission number | |
| * | — | Roth REDTA Chelating Agent Named without a submission number | |
| * | — | Union Broach Endodilator N-O Named without a submission number |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K950365.
How does its category compare?
All EKL devicesEKL Point, Silver, Endodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EKL
FDA has decided no EKL device since 2007.
Median 510(k) review, days · EKL
Too few EKL 510(k)s in any year since 2007 to give a median.
Recalls per year · EKL
No recall names EKL since 2007.
Adverse event reports per year · EKL
No MAUDE report names EKL since 2007.
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 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PULPDENT Endo-Prep II is a 17 % EDTA chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin. PULPDENT Endo-Prep II will be offered in two viscosities, thin and thick, so that the dentist can apply the product either directly to the canal opening or to the file.
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/K961089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961089: Pulpdent Endoprep II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961089
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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