510(k) · Cleared
ClearedDRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drfp, Ltd. · KIF Resin, Root Canal Filling
Cleared on Jun 20, 2012 as substantially equivalent to K100248 (Drfp, Ltd., 2010) after a 166-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Jun 20, 2012
- Review
- 166 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K960548 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK960548 AH Plus Root Canal SealerDentsply Intl. · 1996
- 3 generations backK992727 The BI-Directional Spiral & Epoxy Root Canal Cement SystemMds · 2000
- 2 generations backK042769 Adseal Root Canal SealerMeta Biomed Co., Ltd. · 2004
- 1 generation backK100248 DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SDrfp, Ltd. · 2010
- This deviceK120048 DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints SDrfp, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK202281 EDS Bioceramic Sealer (Bioseal)Essential Dental Systems · 2021
Most influential descendants
Showing 1 of 1 · See all- K202281EDS Bioceramic Sealer (Bioseal)Essential Dental Systems · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960548 | AH Plus Root Canal Sealer | Dentsply Intl. | 1996 | — |
| −3 | K992727 | The BI-Directional Spiral & Epoxy Root Canal Cement System | Mds | 2000 | — |
| −2 | K042769 | Adseal Root Canal Sealer | Meta Biomed Co., Ltd. | 2004 | — |
| −1 | K100248 | DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, S | Drfp, Ltd. | 2010 | — |
| 0 (this device) | K120048 | DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S | Drfp, Ltd. | 2012 | — |
| +1 | K202281 | EDS Bioceramic Sealer (Bioseal) | Essential Dental Systems | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 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 |
|---|---|---|---|
| * | K100248 | DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SSummary page 1…nal Obturation Points Classification Names Resin, Root Canal Filling " Product Code/ CFR KIF Class Il CFR 872.3820 ' Component of ProSmart Root Canal Obturation System K100248 " 5 — §10(k) Summary - 1/4 DRFP Ltd. S Propoints with iRoot SP Sealer . . : : Traditional 510(k) 8§65 Reason fo… | 2010 |
| † | K080917 | Iroot SP | 2008 |
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 |
|---|---|---|---|
| K202281 | EDS Bioceramic Sealer (Bioseal) | 2021 | 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 16 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K202281 (Essential Dental Systems, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K100248.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
DRFP propoint obturation points are designed for permanent sealing of root canals when used with DRFP smartpaste Dental Sealer or Brasseler USA EndoSequence® BC Sealer following established endodontic procedures by qualified healthcare professionals.
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/K120048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120048: DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120048
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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