510(k) · Cleared

Cleared

Iroot SP

K080917510(k) TraditionalCleared Apr 9, 20088-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

Innovative Bioceramix, Inc. · KIF Resin, Root Canal Filling

Cleared on Apr 9, 2008 as substantially equivalent to K960548 (Dentsply Intl., 1996) and 5 other predicates after an 8-day review. Its family tree reaches back 6 generations to 1999. 37 later devices descend from it.

Decided: Apr 9, 2008
Review: 8 days
Class: Class II
Product code: KIF
Recalls: None
Predicates: 6

Its longest line of descent runs back 6 generations to K990131 (1999). 28 ancestors in all, the oldest K852682 (1985). 37 later devices descend from it, 12 citing it directly.

By dateBy generation

Root · 6 generations backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
5 generations backK020986 Mastergraft Resorbable CeramicMedtronic Sofamor Danek, Inc. · 2002
4 generations backK032268 MBCPBiomatlante · 2003
3 generations backK043005 Modification to MBCPBiomatlante · 2005
2 generations backK051885 MBCPBiomatlante · 2005
1 generation backK060732 MBCP GelBiomatlante · 2006
This deviceK080917 Iroot SPInnovative Bioceramix, Inc. · 2008
Descendant · cites it directly · 12 of its ownK082943 Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009
Descendant · cites it directly · 8 of its ownK170175 Endoseal MtaMaruchi · 2018
Descendant · 2 generations on · 7 of its ownK092715 Iroot BP PlusInnovative Bioceramix, Inc. · 2009
Descendant · cites it directly · 4 of its ownK212983 Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021
Descendant · 2 generations on · 3 of its ownK180185 Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A · 2018

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2009high 7 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 37 · See all

K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc. · 2009 · cites it directly12descendants
K170175Endoseal MtaMaruchi · 2018 · cites it directly8descendants
K092715Iroot BP PlusInnovative Bioceramix, Inc. · 2009 · 2 generations on7descendants
K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd. · 2021 · cites it directly4descendants
K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A · 2018 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K990131	Pro Osteon Implant 500R Resorbable Bone Graft Substitute	Interpore Cross Intl.	1999	—
−5	K020986	Mastergraft Resorbable Ceramic	Medtronic Sofamor Danek, Inc.	2002	—
−4	K032268	MBCP	Biomatlante	2003	—
−3	K043005	Modification to MBCP	Biomatlante	2005	—
−2	K051885	MBCP	Biomatlante	2005	—
−1	K060732	MBCP Gel	Biomatlante	2006	—
0 (this device)	K080917	Iroot SP	Innovative Bioceramix, Inc.	2008	—
+1	K082943	Iroot BP, Model Irbp 4609	Innovative Bioceramix, Inc.	2009	—
+1	K170175	Endoseal Mta	Maruchi	2018	—
+2	K092715	Iroot BP Plus	Innovative Bioceramix, Inc.	2009	—
+1	K212983	Injectable Root Canal Bioceramic Sealer	Beijing C-Root Dental Medical Devices Co., Ltd.	2021	—
+2	K180185	Bio-C Repair	Angelus Industria DE Produtos Odontologicos S/A	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1985	1	0
1989	1	0
1993	1	0
1995	2	0
1996	2	0
1997	2	0
1998	1	0
1999	1	0
2000	2	0
2001	4	0
2004	4	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	2	0
2010	1	0
2014	1	0
2018	4	0
2019	2	0
2021	7	0
2022	4	0
2023	4	0
2024	4	0
2025	4	0
2026	4	0

FIG. 1 — Lineage of K080917, 1999–2026Source: 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

Get a 510(k) Report

What was it cleared against? (6)

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
*	K960548	AH Plus Root Canal Sealer Summary page 1 …ON NAME: Resin, Root Canal Filling (21 CFR 872.3820, Product Code: KIF) PREDICATE DEVICES: * AH®0 Plustm Root Canal Sealer (K960548) For specific chemical compositions: * BioAggregate…	Dentsply Intl.	1996	—
*	K063422	Bioaggregate Summary page 1 …m Root Canal Sealer (K960548) For specific chemical compositions: * BioAggregate (K063422) * Apexit® Root Canal Sealer (K893 794) * Exactech Resorbabl…	Innovative Bioceramix, Inc.	2006	—
*	K893794	Apexit Root Canal Sealer Summary page 1 …chemical compositions: * BioAggregate (K063422) * Apexit® Root Canal Sealer (K893 794) * Exactech Resorbable Bone Paste (K020078) * MBCP Gel""…	Williams Dental Co., Inc.	1989	—
*	K020078	Exactech Resorbable Bone Paste Summary page 1 …(K063422) * Apexit® Root Canal Sealer (K893 794) * Exactech Resorbable Bone Paste (K020078) * MBCP Gel"" (K060732) For delivery system:…	Exactech, Inc.	2004	—
*	K060732	MBCP Gel Summary page 1 …(K893 794) * Exactech Resorbable Bone Paste (K020078) * MBCP Gel"" (K060732) For delivery system: * Diapex® (K033585)…	Biomatlante	2006	—
*	K033585	Diapex Summary page 1 …* MBCP Gel"" (K060732) For delivery system: * Diapex® (K033585) DEVICE DESCRIEPTION: iRoot SP Root Canal Sealer (iRoot SP) is a convenient premixed ready-to-…	Bisco, Inc.	2004	—

Also cleared against K960548: 10 other devices →

What descends from it? (37)

See all 37

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

Number	Device	Applicant	Decided	Descendants
K082943	Iroot BP, Model Irbp 4609	Innovative Bioceramix, Inc.	2009	12
K170175	Endoseal Mta	Maruchi	2018	8
K212983	Injectable Root Canal Bioceramic Sealer	Beijing C-Root Dental Medical Devices Co., Ltd.	2021	4
K190503	CeraSeal	Meta Biomed Co., Ltd.	2019	2
K102867	Iroot FS	Innovative Bioceramix, Inc.	2010	2
K172701	Bio-C Sealer	Angelus Industria DE Produtos Odontologicos S/A	2018	1
K261415	Injectable Root Canal Sealer (KP-Root SP)	Guilin Kevin Peter Technology Co., Ltd.	2026	0
K252890	ZenSeal Pro	Kerr Corporation	2026	0
K231259	iRoot SP Plus	Innovative Bioceramix, Inc.	2023	0
K212283	BioRoot Flow 0.5g, BioRoot Flow 2g	Septodont	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 9 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
None of the 28 ancestors has a recall.
Of its descendants, K082943 (Innovative Bioceramix, Inc., 2009) has gone furthest, with 12 descendants of its own.
10 other devices also cite its predicate K960548.

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. 2008, this device’s year, is highlighted.

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?

Permanent obturation of the root canal following vital pulp-extirpation.

Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

iRoot SP is suitable for use in the single cone and lateral condensation technique.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080917 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080917: Iroot SP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080917

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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