510(k) · Cleared
ClearedBiodentine XP 500, Biodentine XP 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Septodont · KIF Resin, Root Canal Filling
Cleared on Aug 10, 2021 as substantially equivalent to K140132 (Septodont, 2014) after a 61-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Aug 10, 2021
- Review
- 61 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K140132 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK140132 BiodentineSeptodont · 2014
- This deviceK211799 Biodentine XP 500, Biodentine XP 200Septodont · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K140132 | Biodentine | Septodont | 2014 | — |
| 0 (this device) | K211799 | Biodentine XP 500, Biodentine XP 200 | Septodont | 2021 | — |
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 KIF? 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 KIF device
- #1 K250710 Injectable Root Canal Bioceramic Sealer (nRoot…score 14.9 · 9 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 |
|---|---|---|---|
| * | K140132 | BiodentineSummary page 4…BiodentineTM Device Classification Name: Resin, Root Canal Filling/Liner, Cavity, Calcium Hydroxide 510(k) Number: K140132 Regulation Number: primary: 872.3820, secondary: 872.3275 Classification Product Code:… | 2014 |
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 KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · KIF
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KIF
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KIF
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KIF
55in 2025
MAUDE reports naming product code KIF, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 31 | 0 | 2 |
| 2009 | 5 | 94 | 1 | 7 |
| 2010 | 5 | 75 | 0 | 10 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 5 | 172 | 0 | 4 |
| 2013 | 2 | — | 0 | 79 |
| 2014 | 10 | 220 | 0 | 421 |
| 2015 | 1 | — | 0 | 15 |
| 2016 | 5 | 212 | 0 | 5 |
| 2017 | 3 | 211 | 0 | 5 |
| 2018 | 5 | 147 | 0 | 13 |
| 2019 | 7 | 252 | 0 | 6 |
| 2020 | 3 | 239 | 0 | 3 |
| 2021 | 12 | 89 | 0 | 9 |
| 2022 | 3 | 152 | 0 | 10 |
| 2023 | 7 | 59 | 0 | 7 |
| 2024 | 8 | 96 | 0 | 10 |
| 2025 | 7 | 90 | 0 | 55 |
| 2026 | 7 | 108 | 0 | — |
What is it indicated for?
In the crown: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): - Permanent dentine restoration under composites or Inlay/Onlay - Temporary dentine-enamel restoration; - Restoration of deep and/or large coronal carious lesions (sandwich technique); - Restoration of cervical or radicular lesions. On the pulp: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): - Pulp…
Read the full statement (134 words)
In the crown:
For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):
- Permanent dentine restoration under composites or Inlay/Onlay
- Temporary dentine-enamel restoration;
- Restoration of deep and/or large coronal carious lesions (sandwich technique);
- Restoration of cervical or radicular lesions.
On the pulp:
For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature):
- Pulp capping (direct and indirect).
- Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes.
In the root:
For permanent teeth (immature or mature):
- Repair of root perforations;
- Repair of furcation perforations;
- Repair of perforating internal resorptions;
- Repair of external resorption;
- Root-end filling in endodontic surgery (retrograde filling).
For immature permanent teeth
- Apexification
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/K211799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211799: Biodentine XP 500, Biodentine XP 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211799
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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