# K100248: DRFP Prosmart Root Canal Obturation System, Propoints 4% 6%, PT, S

- Pathway: 510(k) (Traditional)
- Applicant: Drfp, Ltd.
- Decided: Oct 22, 2010 after 268 days
- Product code: KIF (Resin, Root Canal Filling)
- Device class: 2
- Regulation: 21 CFR 872.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960548 (1996). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042769: Adseal Root Canal Sealer, Meta Biomed Co., Ltd. (2004) Summary page 1.
- (no number) Class I Gutta Percha: named in the summary without a submission number

## Most influential descendants
- K120048: DRFP Propoints, Propoints 4%, Propoints 6%, Propoints PT, Propoints S (2012), 1 descendant of its own
- K202281: EDS Bioceramic Sealer (Bioseal) (2021), 0 descendants of its own

## Indications for use
The DRFP ProSmart Root Canal Obturation System is designed for permanent sealing of root canals following established endodontic procedures by qualified healthcare professionals.

Source page: https://510kreport.com/device/K100248
Methodology: https://510kreport.com/methodology