Product Code: KIF FDA class 2 21 CFR 872.3820

Resin, Root Canal Filling

Dental

Root Canal Filling Resin is a dental material used to seal and fill the root canal system following endodontic treatment, providing an impermeable, biocompatible barrier that prevents reinfection of the canal and supports long-term retention of the treated tooth. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KIF, regulated under 21 CFR 872.3820, within the Dental medical specialty. This device is eligible for third-party review.

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510(k)s

143

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: KIF
Device Class: FDA class 2
Regulation Number: 872.3820
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 143 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253167	Any-Paste	Jan 12, 2026	Substantially Equivalent	Mediclus Co., Ltd.
K252890	ZenSeal Pro	Jan 07, 2026	Substantially Equivalent	Kerr Corporation
K251465	Root canal repair materials (nRoot BP)	Sep 25, 2025	Substantially Equivalent	Enpuno Biotechnology Co., Ltd.
K252285	Well-Root PT	Sep 19, 2025	Substantially Equivalent	Vericom Co., Ltd.
K251884	One-Fil Putty Injectable	Aug 22, 2025	Substantially Equivalent	Mediclus Co., Ltd.
K251390	MTA vpt	Jul 03, 2025	Substantially Equivalent	Voco GmbH
K250710	Injectable Root Canal Bioceramic Sealer (nRoot SP)	Jun 11, 2025	Substantially Equivalent	Enpuno Co., Ltd.
K243353	One-Fil Putty	Mar 14, 2025	Substantially Equivalent	Mediclus Co., Ltd.
K243546	AH Plus Endodontic Sealer	Feb 13, 2025	Substantially Equivalent	Dentsply Sirona, Inc.
K242934	Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)	Dec 12, 2024	Substantially Equivalent	Longly Biotechnology (Wuhan) Co., Ltd.
K242702	VioSeal	Nov 07, 2024	Substantially Equivalent	Spident Co., Ltd.
K241977	Injectable Root Canal Bioceramic Sealer (i-MTA SP)	Oct 03, 2024	Substantially Equivalent	Longly Biotechnology (Wuhan) Co., Ltd.
K241457	Vista BC Putty	Aug 28, 2024	Substantially Equivalent	Inter-Med, Inc.
K240446	Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +	Jul 30, 2024	Substantially Equivalent	Shiva Products
K240304	Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)	May 28, 2024	Substantially Equivalent	Enpuno Biotechnology Co., Ltd.
K240365	Bioceramic Root Repair Material (C-Root BP)	May 10, 2024	Substantially Equivalent	Beijing C-Root Dental Medical Devices Co., Ltd.
K232182	One-Fil	Jan 26, 2024	Substantially Equivalent	Mediclus Co., Ltd.
K232299	CeraPutty	Sep 29, 2023	Substantially Equivalent	Meta Biomed Co., Ltd.
K231480	Bright MTA Sealer Plus	Jul 28, 2023	Substantially Equivalent	Genoss Co., Ltd.
K231387	Endofill	Jul 10, 2023	Substantially Equivalent	Lumendo AG
K231259	iRoot SP Plus	May 31, 2023	Substantially Equivalent	Innovative Bioceramix, Inc.
K230010	ADSEAL Plus	Apr 13, 2023	Substantially Equivalent	Meta Biomed Co., Ltd.
K230797	SmartMTA Capsule	Mar 24, 2023	Substantially Equivalent	Sprig Oral Health Technologies, Inc.
K213757	Endocem MTA Premixed Regular	Feb 14, 2023	Substantially Equivalent	Maruchi
K222992	iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material	Nov 22, 2022	Substantially Equivalent	Innovative Bioceramix, Inc.
K221811	Vista BC Sealer	Nov 21, 2022	Substantially Equivalent	Inter-Med, Inc.
K212563	CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid	May 23, 2022	Substantially Equivalent	Prevest Denpro Limited
K212983	Injectable Root Canal Bioceramic Sealer	Dec 08, 2021	Substantially Equivalent	Beijing C-Root Dental Medical Devices Co., Ltd.
K211905	UltraCal XS	Oct 13, 2021	Substantially Equivalent	Ultradent Products, Inc.
K212283	BioRoot Flow 0.5g, BioRoot Flow 2g	Sep 16, 2021	Substantially Equivalent	Septodont
K211995	Sonendo Filling Material 5C	Aug 27, 2021	Substantially Equivalent	Sonendo, Inc.
K212229	White Endoseal MTA	Aug 13, 2021	Substantially Equivalent	Maruchi
K211799	Biodentine XP 500, Biodentine XP 200	Aug 10, 2021	Substantially Equivalent	Septodont
K210904	Metapaste Plus	Jun 30, 2021	Substantially Equivalent	Meta Biomed Co., Ltd.
K202617	Metapex Plus	Apr 14, 2021	Substantially Equivalent	Meta Biomed Co., Ltd.
K210333	DiaPaste	Mar 25, 2021	Substantially Equivalent	DiaDent Group International
K202015	White ENDOSEAL MTA	Mar 24, 2021	Substantially Equivalent	Maruchi
K202281	EDS Bioceramic Sealer (Bioseal)	Feb 12, 2021	Substantially Equivalent	Essential Dental Systems
K201222	Bio-C Repair Ion+	Feb 11, 2021	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A
K200174	DIA-ROOT BIO MTA	Sep 18, 2020	Substantially Equivalent	DiaDent Group International
K200175	DIA-ROOT BIO Sealer	Jun 25, 2020	Substantially Equivalent	DiaDent Group International
K190091	Diapaste	Mar 27, 2020	Substantially Equivalent	DiaDent Group International
K190537	BIO-C Sealer Ion+	Dec 12, 2019	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A
K182009	Dia-Proseal	Sep 26, 2019	Substantially Equivalent	DiaDent Group International
K190503	CeraSeal	Jun 07, 2019	Substantially Equivalent	Meta Biomed Co., Ltd.
K182625	Diapex Plus	Jun 03, 2019	Substantially Equivalent	DiaDent Group International
K190510	GuttaSil	May 29, 2019	Substantially Equivalent	Meta Biomed Co., Ltd.
K181917	MTA2.3 MATERIALS	Jan 11, 2019	Substantially Equivalent	NuSmile, Ltd.
K180199	BIO-C TEMP	Jan 04, 2019	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A
K181922	Sonendo Material A	Oct 22, 2018	Substantially Equivalent	Sonendo, Inc.
K180185	BIO-C REPAIR	Aug 31, 2018	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A
K170175	ENDOSEAL MTA	Feb 26, 2018	Substantially Equivalent	Maruchi
K172839	ENDOSOLV	Feb 13, 2018	Substantially Equivalent	Septodont
K172701	BIO-C SEALER	Jan 04, 2018	Substantially Equivalent	Angelus Industria DE Produtos Odontologicos S/A
K170950	Well-Root ST	Dec 20, 2017	Substantially Equivalent	Vericom Co., Ltd.
K170207	Obturys	Jul 31, 2017	Substantially Equivalent	Itena Clinical
K162661	SavDenTM MTA Root Canal Filling Materials	Apr 25, 2017	Substantially Equivalent	Tyds Biotech Incorporation
K161239	MTA2.2 MATERIAL	Sep 01, 2016	Substantially Equivalent	Avalon Biomed, Inc.
K151047	MTA Repair HP	Aug 31, 2016	Substantially Equivalent	Angelus Industria DE Productos Odontologicos
K153067	Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress	Jul 27, 2016	Substantially Equivalent	Sybron Dental Specialties
K152956	Pulp Canal Sealer, Pulp Canal Sealer EWT	May 06, 2016	Substantially Equivalent	Sybron Dental Specialties
K152959	Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes	Apr 14, 2016	Substantially Equivalent	Sybron Dental Specialties
K142178	PROROOT MTA WHITE, PROROOT MTA GRAY	Feb 26, 2015	Substantially Equivalent	Dentsply International, Inc.
K130312	IROOT FM	Sep 18, 2014	Substantially Equivalent	Innovative Bioceramix, Inc.
K140132	BIODENTINE	Jun 27, 2014	Substantially Equivalent	Septodont
K140955	MTA2.1 MATERIAL	Jun 11, 2014	Substantially Equivalent	Avalon Biomed, Inc.
K133054	ENDOSEAL	May 12, 2014	Substantially Equivalent	Maruchi
K133042	ENDOCEM ZR	May 12, 2014	Substantially Equivalent	Maruchi
K140247	MTA FILLAPEX	Apr 25, 2014	Substantially Equivalent	Angelus Industria DE Productos Odontologicos SA
K132825	RETROMTA-ORTHOMTA II	Apr 10, 2014	Substantially Equivalent	Biomta
K133716	TRC-PASTE	Apr 09, 2014	Substantially Equivalent	Km Corporation
K132123	TRC-PEX, RADIC-SEALER	Mar 20, 2014	Substantially Equivalent	Km Corporation
K123276	MM-SEAL	Mar 10, 2014	Substantially Equivalent	Micro-Mega Societe Anonyme
K130601	BIOROOT RCS	Oct 17, 2013	Substantially Equivalent	Novocol, Inc.
K130125	MTA CEMENTS	Jul 24, 2013	Substantially Equivalent	S&C Polymer Silicon- Und Composite Spezialitaeten
K122892	MTA2 ROOT AND PULP MATERIALS	Dec 11, 2012	Substantially Equivalent	Avalon Biomed, Inc.
K113568	MTA-FILLAPEX	Aug 21, 2012	Substantially Equivalent	Paxmed International
K120048	DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S	Jun 20, 2012	Substantially Equivalent	Drfp , Ltd.
K112078	ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE)	Mar 19, 2012	Substantially Equivalent	Maruchi
K112046	MTA ANGELUS	Jan 06, 2012	Substantially Equivalent	Angelus Industria DE Productos Odontologicos
K102867	IROOT FS	Dec 03, 2010	Substantially Equivalent	Innovative Bioceramix, Inc.
K102575	ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)	Oct 29, 2010	Substantially Equivalent	Do Co., Ltd.
K100248	DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S	Oct 22, 2010	Substantially Equivalent	Drfp , Ltd.
K102163	REALSEAL XT SEALER	Oct 16, 2010	Substantially Equivalent	Kerr Corporation
K093208	SIMPLISEAL	Feb 12, 2010	Substantially Equivalent	Discus Dental, LLC
K092251	BIODENTINE	Oct 30, 2009	Substantially Equivalent	Septodont
K092715	IROOT BP PLUS	Sep 28, 2009	Substantially Equivalent	Innovative Bioceramix, Inc.
K090992	WELL-PASTE	Apr 21, 2009	Substantially Equivalent	Vericom Co., Ltd.
K083062	ROOT CANAL XR	Mar 12, 2009	Substantially Equivalent	S & C Polymer GmbH
K082943	IROOT BP, MODEL IRBP 4609	Jan 06, 2009	Substantially Equivalent	Innovative Bioceramix, Inc.
K080917	IROOT SP	Apr 09, 2008	Substantially Equivalent	Innovative Bioceramix, Inc.
K080203	MTA ROOT CANAL SEALER	Mar 26, 2008	Substantially Equivalent	Dentsply Interntional
K080266	WELL-PEX	Feb 06, 2008	Substantially Equivalent	Vericom Co., Ltd.
K073218	MTA ADVANCED MATERIAL	Jan 07, 2008	Substantially Equivalent	Dentsply Interntional
K071106	ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399	May 08, 2007	Substantially Equivalent	Ultradent Products, Inc.
K063856	EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM	Feb 06, 2007	Substantially Equivalent	Essential Dental Systems, Inc.
K063422	BIOAGGREGATE	Nov 21, 2006	Substantially Equivalent	Innovative Bioceramix, Inc.
K060889	SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE	Oct 27, 2006	Substantially Equivalent	Pentron Clinical Technologies
K060946	CZ-S2000	Jun 15, 2006	Substantially Equivalent	Parkell, Inc.
K042769	ADSEAL ROOT CANAL SEALER	Nov 24, 2004	Substantially Equivalent	Meta Biomed Co., Ltd.
K042756	ENDOREZ	Oct 26, 2004	Substantially Equivalent	Ultradent Products, Inc.
K033585	DIAPEX	Jan 16, 2004	Substantially Equivalent	Bisco, Inc.
K032662	GUTTAFLOW	Nov 03, 2003	Substantially Equivalent	Coltene/Whaledent GmbH & Co. KG
K032605	METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING	Oct 08, 2003	Substantially Equivalent	Meta Biomed Co., Ltd.
K032603	METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING	Oct 07, 2003	Substantially Equivalent	Meta Biomed Co., Ltd.
K023818	FIBERFILL AGP	Apr 03, 2003	Substantially Equivalent	Pentron Clinical Technologies
K023976	ACROSEAL ROOT CANAL OR APICAL SEALER	Jan 30, 2003	Substantially Equivalent	Septodont S.A.S.
K022734	PULPDENT CALCIUM HYDROXIDE PREPARATION	Oct 07, 2002	Substantially Equivalent	Pulpdent Corporation
K011748	FIRST FILL R.C.S.	Aug 03, 2001	Substantially Equivalent	Jeneric/Pentron, Inc.
K010940	SEALAPEX 4	Jun 20, 2001	Substantially Equivalent	Sybron Dental Specialties, Inc.
K011009	WHITE MTA MATERIAL	May 02, 2001	Substantially Equivalent	Dentsply International
K992727	THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM	Jan 18, 2000	Substantially Equivalent	Mds
K992097	ENDOREZ	Oct 26, 1999	Substantially Equivalent	Ultradent Products, Inc.
K983037	ROEKO SEAL	Oct 20, 1998	Substantially Equivalent	Roeko Ulm, Roescheisen GmbH & Co.
K981620	MTA MATERIAL II	Jul 31, 1998	Substantially Equivalent	Dentsply Intl.
K980633	ENDOSOLV E	May 01, 1998	Substantially Equivalent	Specialites Septodont
K980332	MTA MATERIAL	Feb 24, 1998	Substantially Equivalent	Dentsply Intl.
K973667	VITAPEX PRE-LOADED DENTAL SYRINGE	Nov 06, 1997	Substantially Equivalent	Neodental Chemical Products Co., Ltd.
K972369	SEALAPEX	Aug 15, 1997	Substantially Equivalent	Sybron Dental Specialties, Inc.
K971899	ENDO-SEAL	Jun 26, 1997	Substantially Equivalent	Ultradent Products, Inc.
K971622	MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM	Jun 20, 1997	Substantially Equivalent	Mpl Technologies, Inc.
K964174	MINERAL TRIOXIDE AGGREGATE (MTA)	Feb 10, 1997	Substantially Equivalent	Tulsa Dental Products, Ltd.
K963922	ALPHA-DENT ROOT CANAL SEALER & FILLER	Dec 06, 1996	Substantially Equivalent	Wallace A. Erickson & Co.
K962885	SEALEX EXTRA ROOT CANAL SEALER	Aug 30, 1996	Substantially Equivalent	Baladent
K955703	NEO DENTAL ENDODONTIC IRRIGATION SYRINGE	May 20, 1996	Substantially Equivalent	Neodental Chemical Products Co., Ltd.
K960548	AH PLUS ROOT CANAL SEALER	Apr 26, 1996	Substantially Equivalent	Dentsply Intl.
K946138	PULPDENT ROOT CANAL SEALER	Jan 20, 1995	Substantially Equivalent	Pulpdent Corp.
K940368	CANAL KING (THIN) CANAL KING (THICK)	Jan 20, 1995	Substantially Equivalent	Pulpdent Corp.
K942393	TUBLI-SEAL EWT	Jun 10, 1994	Substantially Equivalent	Sybron Dental Specialties, Inc.
K930872	ALPHA-DENT ROOT CANAL SEALER; WACH'S FORMULA	Feb 01, 1994	Substantially Equivalent	Wallace A. Erickson & Co.
K932791	PULPDENT EDTA PREPARATIONS	Sep 20, 1993	Substantially Equivalent	Pulpdent Corp.
K914325	ROOT CANAL FILLING CEMENT	Mar 09, 1992	Substantially Equivalent	Confi-Dental Products Co.
K896657	ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA	Feb 14, 1990	Substantially Equivalent	Pulpdent Corp.
K896656	ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH	Feb 14, 1990	Substantially Equivalent	Pulpdent Corp.
K894092	DENTAL ENDODONTIC CEMENT (MODIFICATION)	Jan 10, 1990	Substantially Equivalent	The Hygenic Corp.
K893794	APEXIT ROOT CANAL SEALER	Nov 29, 1989	Substantially Equivalent	Williams Dental Co., Inc.
K854253	ROOT CANAL FILLING RESIN	Dec 16, 1985	Substantially Equivalent	Dentsply Intl.
K844635	HYDROSET ROOT CANAL SEALER	Feb 19, 1985	Substantially Equivalent	Lund Manufacturing Co.
K830763	FR ROOT CANAL FILLER	Aug 26, 1983	Substantially Equivalent	Shizai Corp.
K820284	ROOT CANAL FILLING RESIN	Mar 19, 1982	Substantially Equivalent	Dentsply Intl.
K810923	LEE ENDOFILL, ROOT CANAL FILLING RESIN	Apr 21, 1981	Substantially Equivalent	Lee Pharmaceuticals
K801482	HYDRON ROOT CANAL FILLING MATERIAL	Jul 21, 1980	Substantially Equivalent	National Patent Development Corp.
K771921	HYDRON ROOT CANAL FILLING SYSTEM	Nov 15, 1977	Substantially Equivalent	National Patent Development Corp.