Atlas FDA

KIF

144 FDA 510(k) clearances · Product code

96 daysmedian time to decision
268 days90th percentile
144clearances measured

FDA profile

Official device name
Resin, Root Canal Filling
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3820
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2013: 79 · 2014: 421 · 2015: 15 · 2018: 13 · 2025: 55 · 2026: 14
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Injectable Root Canal Sealer (KP-Root SP) (K261415)Guilin Kevin Peter Technology Co., Ltd.2026-06-29
Any-Paste (K253167)Mediclus Co., Ltd.2026-01-12
ZenSeal Pro (K252890)Kerr Corporation2026-01-07
Root canal repair materials (nRoot BP) (K251465)Enpuno Biotechnology Co., Ltd.2025-09-25
Well-Root PT (K252285)Vericom Co., Ltd.2025-09-19
One-Fil Putty Injectable (K251884)Mediclus Co., Ltd.2025-08-22
MTA vpt (K251390)Voco GmbH2025-07-03
Injectable Root Canal Bioceramic Sealer (nRoot SP) (K250710)Enpuno Co., Ltd.2025-06-11
One-Fil Putty (K243353)Mediclus Co., Ltd.2025-03-14
AH Plus Endodontic Sealer (K243546)Dentsply Sirona, Inc.2025-02-13
Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (K242934)Longly Biotechnology (Wuhan) Co., Ltd.2024-12-12
VioSeal (K242702)Spident Co., Ltd.2024-11-07
Injectable Root Canal Bioceramic Sealer (i-MTA SP) (K241977)Longly Biotechnology (Wuhan) Co., Ltd.2024-10-03
Vista BC Putty (K241457)Inter-Med, Inc.2024-08-28
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + (K240446)Shiva Products2024-07-30
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) (K240304)Enpuno Biotechnology Co., Ltd.2024-05-28
Bioceramic Root Repair Material (C-Root BP) (K240365)Beijing C-Root Dental Medical Devices Co., Ltd.2024-05-10
One-Fil (K232182)Mediclus Co., Ltd.2024-01-26
CeraPutty (K232299)Meta Biomed Co., Ltd.2023-09-29
Bright MTA Sealer Plus (K231480)Genoss Co., Ltd.2023-07-28
Endofill (K231387)Lumendo AG2023-07-10
iRoot SP Plus (K231259)Innovative Bioceramix, Inc.2023-05-31
ADSEAL Plus (K230010)Meta Biomed Co., Ltd.2023-04-13
SmartMTA Capsule (K230797)Sprig Oral Health Technologies, Inc.2023-03-24
Endocem MTA Premixed Regular (K213757)Maruchi2023-02-14
iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material (K222992)Innovative Bioceramix, Inc.2022-11-22
Vista BC Sealer (K221811)Inter-Med, Inc.2022-11-21
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid (K212563)Prevest Denpro Limited2022-05-23
Injectable Root Canal Bioceramic Sealer (K212983)Beijing C-Root Dental Medical Devices Co., Ltd.2021-12-08
UltraCal XS (K211905)Ultradent Products, Inc.2021-10-13
BioRoot Flow 0.5g, BioRoot Flow 2g (K212283)Septodont2021-09-16
Sonendo Filling Material 5C (K211995)Sonendo, Inc.2021-08-27
White Endoseal MTA (K212229)Maruchi2021-08-13
Biodentine XP 500, Biodentine XP 200 (K211799)Septodont2021-08-10
Metapaste Plus (K210904)Meta Biomed Co., Ltd.2021-06-30
Metapex Plus (K202617)Meta Biomed Co., Ltd.2021-04-14
DiaPaste (K210333)DiaDent Group International2021-03-25
White ENDOSEAL MTA (K202015)Maruchi2021-03-24
EDS Bioceramic Sealer (Bioseal) (K202281)Essential Dental Systems2021-02-12
Bio-C Repair Ion+ (K201222)Angelus Industria DE Produtos Odontologicos S/A2021-02-11
DIA-ROOT BIO MTA (K200174)DiaDent Group International2020-09-18
DIA-ROOT BIO Sealer (K200175)DiaDent Group International2020-06-25
Diapaste (K190091)DiaDent Group International2020-03-27
BIO-C Sealer Ion+ (K190537)Angelus Industria DE Produtos Odontologicos S/A2019-12-12
Dia-Proseal (K182009)DiaDent Group International2019-09-26
CeraSeal (K190503)Meta Biomed Co., Ltd.2019-06-07
Diapex Plus (K182625)DiaDent Group International2019-06-03
GuttaSil (K190510)Meta Biomed Co., Ltd.2019-05-29
MTA2.3 MATERIALS (K181917)NuSmile, Ltd.2019-01-11
BIO-C TEMP (K180199)Angelus Industria DE Produtos Odontologicos S/A2019-01-04
Sonendo Material A (K181922)Sonendo, Inc.2018-10-22
BIO-C REPAIR (K180185)Angelus Industria DE Produtos Odontologicos S/A2018-08-31
ENDOSEAL MTA (K170175)Maruchi2018-02-26
ENDOSOLV (K172839)Septodont2018-02-13
BIO-C SEALER (K172701)Angelus Industria DE Produtos Odontologicos S/A2018-01-04
Well-Root ST (K170950)Vericom Co., Ltd.2017-12-20
Obturys (K170207)Itena Clinical2017-07-31
SavDenTM MTA Root Canal Filling Materials (K162661)Tyds Biotech Incorporation2017-04-25
MTA2.2 MATERIAL (K161239)Avalon Biomed, Inc.2016-09-01
MTA Repair HP (K151047)Angelus Industria DE Productos Odontologicos2016-08-31
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress (K153067)Sybron Dental Specialties2016-07-27
Pulp Canal Sealer, Pulp Canal Sealer EWT (K152956)Sybron Dental Specialties2016-05-06
Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes (K152959)Sybron Dental Specialties2016-04-14
PROROOT MTA WHITE, PROROOT MTA GRAY (K142178)Dentsply International, Inc.2015-02-26
IROOT FM (K130312)Innovative Bioceramix, Inc.2014-09-18
BIODENTINE (K140132)Septodont2014-06-27
MTA2.1 MATERIAL (K140955)Avalon Biomed, Inc.2014-06-11
ENDOSEAL (K133054)Maruchi2014-05-12
ENDOCEM ZR (K133042)Maruchi2014-05-12
MTA FILLAPEX (K140247)Angelus Industria DE Productos Odontologicos SA2014-04-25
RETROMTA-ORTHOMTA II (K132825)Biomta2014-04-10
TRC-PASTE (K133716)Km Corporation2014-04-09
TRC-PEX, RADIC-SEALER (K132123)Km Corporation2014-03-20
MM-SEAL (K123276)Micro-Mega Societe Anonyme2014-03-10
BIOROOT RCS (K130601)Novocol, Inc.2013-10-17
MTA CEMENTS (K130125)S&C Polymer Silicon- Und Composite Spezialitaeten2013-07-24
MTA2 ROOT AND PULP MATERIALS (K122892)Avalon Biomed, Inc.2012-12-11
MTA-FILLAPEX (K113568)Paxmed International2012-08-21
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S (K120048)Drfp , Ltd.2012-06-20
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) (K112078)Maruchi2012-03-19
MTA ANGELUS (K112046)Angelus Industria DE Productos Odontologicos2012-01-06
IROOT FS (K102867)Innovative Bioceramix, Inc.2010-12-03
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) (K102575)Do Co., Ltd.2010-10-29
DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S (K100248)Drfp , Ltd.2010-10-22
REALSEAL XT SEALER (K102163)Kerr Corporation2010-10-16
SIMPLISEAL (K093208)Discus Dental, LLC2010-02-12
BIODENTINE (K092251)Septodont2009-10-30
IROOT BP PLUS (K092715)Innovative Bioceramix, Inc.2009-09-28
WELL-PASTE (K090992)Vericom Co., Ltd.2009-04-21
ROOT CANAL XR (K083062)S & C Polymer GmbH2009-03-12
IROOT BP, MODEL IRBP 4609 (K082943)Innovative Bioceramix, Inc.2009-01-06
IROOT SP (K080917)Innovative Bioceramix, Inc.2008-04-09
MTA ROOT CANAL SEALER (K080203)Dentsply Interntional2008-03-26
WELL-PEX (K080266)Vericom Co., Ltd.2008-02-06
MTA ADVANCED MATERIAL (K073218)Dentsply Interntional2008-01-07
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 (K071106)Ultradent Products, Inc.2007-05-08
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM (K063856)Essential Dental Systems, Inc.2007-02-06
BIOAGGREGATE (K063422)Innovative Bioceramix, Inc.2006-11-21
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE (K060889)Pentron Clinical Technologies2006-10-27
CZ-S2000 (K060946)Parkell, Inc.2006-06-15
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