510(k) · Cleared

Cleared

First Fill R.C.S.

K011748510(k) TraditionalCleared Aug 3, 200158-day reviewClass II21 CFR 872.3820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Jeneric/Pentron, Inc. · KIF Resin, Root Canal Filling

Cleared on Aug 3, 2001 as substantially equivalent to K992097 (Ultradent Products, Inc., 1999) after a 58-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.

Decided: Aug 3, 2001
Review: 58 days
Class: Class II
Product code: KIF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K992097 (1999). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK992097 EndorezUltradent Products, Inc. · 1999
This deviceK011748 First Fill R.C.S.Jeneric/Pentron, Inc. · 2001
Descendant · cites it directly · 0 of its ownK060889 SE Epiphany Root Canal Sealant, Model N59SEPentron Clinical Technologies · 2006
Descendant · cites it directly · 0 of its ownK052800 Provisional Inlay/Onlay KitDmg USA, Inc. · 2006

Most influential descendants

Showing 2 of 2 · See all

K060889SE Epiphany Root Canal Sealant, Model N59SEPentron Clinical Technologies · 2006 · cites it directly0descendants
K052800Provisional Inlay/Onlay KitDmg USA, Inc. · 2006 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K992097	Endorez	Ultradent Products, Inc.	1999	—
0 (this device)	K011748	First Fill R.C.S.	Jeneric/Pentron, Inc.	2001	—
+1	K060889	SE Epiphany Root Canal Sealant, Model N59SE	Pentron Clinical Technologies	2006	—
+1	K052800	Provisional Inlay/Onlay Kit	Dmg USA, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0

FIG. 1 — Lineage of K011748, 1999–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K992097	Endorez Summary page 1 …n with root canal points. Despite minor differences in the materials, we believe FIRST FILL R.C.S. is substantially equivalent to Ultradent’s EndoRez Root Canal Sealant, K992097. The resins used in First Fill RCS are the common dental methacrylate resins. The fillers are also the common used ones for vario…	Ultradent Products, Inc.	1999	—

Also cleared against K992097: 1 other device →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060889	SE Epiphany Root Canal Sealant, Model N59SE	Pentron Clinical Technologies	2006	0
K052800	Provisional Inlay/Onlay Kit	Dmg USA, Inc.	2006	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?

Its one ancestor has no recall.
Of its descendants, K060889 (Pentron Clinical Technologies, 2006) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K992097.

How does its category compare?

All KIF devices

KIF Resin, Root Canal Filling: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KIF

7in 2025

2007high 12 (2021) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KIF

90in 2025

2007high 252 (2019) · low 31 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KIF

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KIF

55in 2025

2007high 421 (2014) · low 0 (2007)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?

FIRST FILL R.C.S. is to be used for permanent obturation of root canals of teeth in combination with root canal points.

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/K011748 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011748: First Fill R.C.S..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011748

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026