510(k) · Cleared
ClearedDRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, 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 Oct 22, 2010 as substantially equivalent to K042769 (Meta Biomed Co., Ltd., 2004) after a 268-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- Oct 22, 2010
- Review
- 268 days
- Class
- Class II
- Product code
- KIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960548 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK960548 AH Plus Root Canal SealerDentsply Intl. · 1996
- 2 generations backK992727 The BI-Directional Spiral & Epoxy Root Canal Cement SystemMds · 2000
- 1 generation backK042769 Adseal Root Canal SealerMeta Biomed Co., Ltd. · 2004
- This deviceK100248 DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, SDrfp, Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK120048 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960548 | AH Plus Root Canal Sealer | Dentsply Intl. | 1996 | — |
| −2 | K992727 | The BI-Directional Spiral & Epoxy Root Canal Cement System | Mds | 2000 | — |
| −1 | K042769 | Adseal Root Canal Sealer | Meta Biomed Co., Ltd. | 2004 | — |
| 0 (this device) | K100248 | DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, S | Drfp, Ltd. | 2010 | — |
| +1 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K042769 | Adseal Root Canal SealerSummary page 1…ion [807.81(3)(i)j New Device 2.6 Predicate Devices [807.92(a)(3)] Paste K042769 ADSEAL Root Canal Filling KIF CFR 872.3820… | 2004 |
| * | — | Class I Gutta Percha Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120048 (Drfp, Ltd., 2012) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K042769.
How does its category compare?
All KIF devicesKIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The DRFP ProSmart Root Canal Obturation System is designed for permanent sealing of root canals following established endodontic procedures by qualified healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100248: DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100248
Report an extraction error
Are you the manufacturer?
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