FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K112046 |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
MTA ANGELUS |
01/06/2012 |
K151047 |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
MTA Repair HP |
08/31/2016 |
K140247 |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA |
MTA FILLAPEX |
04/25/2014 |
K180185 |
Angelus Industria de Produtos Odontologicos S/A |
BIO-C REPAIR |
08/31/2018 |
K201222 |
Angelus Industria de Produtos Odontologicos S/A |
Bio-C Repair Ion+ |
02/11/2021 |
K172701 |
Angelus Industria de Produtos Odontologicos S/A |
BIO-C SEALER |
01/04/2018 |
K190537 |
Angelus Industria de Produtos Odontologicos S/A |
BIO-C Sealer Ion+ |
12/12/2019 |
K180199 |
Angelus Industria de Produtos Odontologicos S/A |
BIO-C TEMP |
01/04/2019 |
K122892 |
AVALON BIOMED INC. |
MTA2 ROOT AND PULP MATERIALS |
12/11/2012 |
K140955 |
AVALON BIOMED INC. |
MTA2.1 MATERIAL |
06/11/2014 |
K161239 |
AVALON BIOMED INC. |
MTA2.2 MATERIAL |
09/01/2016 |
K962885 |
BALADENT |
SEALEX EXTRA ROOT CANAL SEALER |
08/30/1996 |
K212983 |
Beijing C-Root Dental Medical Devices Co., LTD. |
Injectable Root Canal Bioceramic Sealer |
12/08/2021 |
K132825 |
BIOMTA |
RETROMTA-ORTHOMTA II |
04/10/2014 |
K033585 |
BISCO, INC. |
DIAPEX |
01/16/2004 |
K032662 |
COLTENE/WHALEDENT GMBH & CO. KG |
GUTTAFLOW |
11/03/2003 |
K011009 |
DENTSPLY INTERNATIONAL |
WHITE MTA MATERIAL |
05/02/2001 |
K142178 |
DENTSPLY INTERNATIONAL INC. |
PROROOT MTA WHITE, PROROOT MTA GRAY |
02/26/2015 |
K073218 |
DENTSPLY INTERNTIONAL |
MTA ADVANCED MATERIAL |
01/07/2008 |
K080203 |
DENTSPLY INTERNTIONAL |
MTA ROOT CANAL SEALER |
03/26/2008 |
K960548 |
DENTSPLY INTL. |
AH PLUS ROOT CANAL SEALER |
04/26/1996 |
K980332 |
DENTSPLY INTL. |
MTA MATERIAL |
02/24/1998 |
K981620 |
DENTSPLY INTL. |
MTA MATERIAL II |
07/31/1998 |
K182009 |
Diadent Group International |
Dia-Proseal |
09/26/2019 |
K200174 |
Diadent Group International |
DIA-ROOT BIO MTA |
09/18/2020 |
K200175 |
Diadent Group International |
DIA-ROOT BIO Sealer |
06/25/2020 |
K210333 |
Diadent Group International |
DiaPaste |
03/25/2021 |
K190091 |
Diadent Group International |
Diapaste |
03/27/2020 |
K182625 |
Diadent Group International |
Diapex Plus |
06/03/2019 |
K093208 |
DISCUS DENTAL, LLC |
SIMPLISEAL |
02/12/2010 |
K102575 |
DO CO., LTD. |
ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) |
10/29/2010 |
K100248 |
DRFP LTD |
DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S |
10/22/2010 |
K120048 |
DRFP LTD. |
DRFP PROPOINTS, PROPOINTS 4%, PROPOINTS 6%, PROPOINTS PT, PROPOINTS S |
06/20/2012 |
K202281 |
Essential Dental Systems |
EDS Bioceramic Sealer (Bioseal) |
02/12/2021 |
K063856 |
ESSENTIAL DENTAL SYSTEMS, INC. |
EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM |
02/06/2007 |
K231480 |
Genoss Co., Ltd. |
Bright MTA Sealer Plus |
07/28/2023 |
K063422 |
INNOVATIVE BIOCERAMIX INC. |
BIOAGGREGATE |
11/21/2006 |
K092715 |
INNOVATIVE BIOCERAMIX INC. |
IROOT BP PLUS |
09/28/2009 |
K222992 |
Innovative BioCeramix Inc. |
iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material |
11/22/2022 |
K082943 |
INNOVATIVE BIOCERAMIX INC. |
IROOT BP, MODEL IRBP 4609 |
01/06/2009 |
K130312 |
INNOVATIVE BIOCERAMIX INC. |
IROOT FM |
09/18/2014 |
K102867 |
INNOVATIVE BIOCERAMIX INC. |
IROOT FS |
12/03/2010 |
K080917 |
INNOVATIVE BIOCERAMIX INC. |
IROOT SP |
04/09/2008 |
K231259 |
Innovative BioCeramix, Inc. |
iRoot SP Plus |
05/31/2023 |
K221811 |
Inter-Med, Inc. |
Vista BC Sealer |
11/21/2022 |
K170207 |
Itena Clinical |
Obturys |
07/31/2017 |
K011748 |
JENERIC/PENTRON, INC. |
FIRST FILL R.C.S. |
08/03/2001 |
K102163 |
KERR CORPORATION |
REALSEAL XT SEALER |
10/16/2010 |
K133716 |
KM CORPORATION |
TRC-PASTE |
04/09/2014 |
K132123 |
KM CORPORATION |
TRC-PEX, RADIC-SEALER |
03/20/2014 |
K231387 |
Lumendo AG |
Endofill |
07/10/2023 |
K112078 |
MARUCHI |
ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) |
03/19/2012 |
K213757 |
Maruchi |
Endocem MTA Premixed Regular |
02/14/2023 |
K133042 |
MARUCHI |
ENDOCEM ZR |
05/12/2014 |
K133054 |
MARUCHI |
ENDOSEAL |
05/12/2014 |
K170175 |
MARUCHI |
ENDOSEAL MTA |
02/26/2018 |
K202015 |
Maruchi |
White ENDOSEAL MTA |
03/24/2021 |
K212229 |
MARUCHI |
White Endoseal MTA |
08/13/2021 |
K992727 |
MDS |
THE BI-DIRECTIONAL SPIRAL & EPOXY ROOT CANAL CEMENT SYSTEM |
01/18/2000 |
K230010 |
Meta Biomed Co., LTD. |
ADSEAL Plus |
04/13/2023 |
K042769 |
META BIOMED CO., LTD. |
ADSEAL ROOT CANAL SEALER |
11/24/2004 |
K232299 |
Meta Biomed Co., Ltd. |
CeraPutty |
09/29/2023 |
K190503 |
Meta Biomed Co., Ltd. |
CeraSeal |
06/07/2019 |
K190510 |
Meta Biomed Co., Ltd. |
GuttaSil |
05/29/2019 |
K032605 |
META BIOMED CO., LTD. |
METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING |
10/08/2003 |
K210904 |
Meta Biomed Co., Ltd. |
Metapaste Plus |
06/30/2021 |
K032603 |
META BIOMED CO., LTD. |
METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING |
10/07/2003 |
K202617 |
Meta Biomed Co., Ltd. |
Metapex Plus |
04/14/2021 |
K123276 |
MICRO-MEGA SOCIETE ANONYME |
MM-SEAL |
03/10/2014 |
K971622 |
MPL TECHNOLOGIES, INC. |
MAX-I-PROBE ENDODONTIC SEALER DELIVERY SYSTEM |
06/20/1997 |
K955703 |
NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
NEO DENTAL ENDODONTIC IRRIGATION SYRINGE |
05/20/1996 |
K973667 |
NEO DENTAL CHEMICAL PRODUCTS CO., LTD. |
VITAPEX PRE-LOADED DENTAL SYRINGE |
11/06/1997 |
K130601 |
NOVOCOL, INC. |
BIOROOT RCS |
10/17/2013 |
K181917 |
NuSmile, LTD. |
MTA2.3 MATERIALS |
01/11/2019 |
K060946 |
PARKELL, INC. |
CZ-S2000 |
06/15/2006 |
K113568 |
PAXMED INTERNATIONAL |
MTA-FILLAPEX |
08/21/2012 |
K023818 |
PENTRON CLINICAL TECHNOLOGIES |
FIBERFILL AGP |
04/03/2003 |
K060889 |
PENTRON CLINICAL TECHNOLOGIES |
SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE |
10/27/2006 |
K212563 |
Prevest Denpro Limited |
CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid |
05/23/2022 |
K022734 |
PULPDENT CORPORATION |
PULPDENT CALCIUM HYDROXIDE PREPARATION |
10/07/2002 |
K983037 |
ROEKO ULM, ROESCHEISEN GMBH & CO. |
ROEKO SEAL |
10/20/1998 |
K083062 |
S & C POLYMER GMBH |
ROOT CANAL XR |
03/12/2009 |
K130125 |
S&C POLYMER SILICON- UND COMPOSITE SPEZIALITAETEN |
MTA CEMENTS |
07/24/2013 |
K092251 |
SEPTODONT |
BIODENTINE |
10/30/2009 |
K140132 |
SEPTODONT |
BIODENTINE |
06/27/2014 |
K211799 |
Septodont |
Biodentine XP 500, Biodentine XP 200 |
08/10/2021 |
K212283 |
Septodont |
BioRoot Flow 0.5g, BioRoot Flow 2g |
09/16/2021 |
K172839 |
Septodont |
ENDOSOLV |
02/13/2018 |
K023976 |
SEPTODONT S.A.S. |
ACROSEAL ROOT CANAL OR APICAL SEALER |
01/30/2003 |
K211995 |
Sonendo, Inc. |
Sonendo Filling Material 5C |
08/27/2021 |
K181922 |
Sonendo, Inc. |
Sonendo Material A |
10/22/2018 |
K980633 |
SPECIALITES SEPTODONT |
ENDOSOLV E |
05/01/1998 |
K230797 |
Sprig Oral Health Technologies, Inc. |
SmartMTA Capsule |
03/24/2023 |
K152956 |
SYBRON DENTAL SPECIALTIES |
Pulp Canal Sealer, Pulp Canal Sealer EWT |
05/06/2016 |
K152959 |
Sybron Dental Specialties |
Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes |
04/14/2016 |
K153067 |
SYBRON DENTAL SPECIALTIES |
Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress |
07/27/2016 |
K972369 |
SYBRON DENTAL SPECIALTIES, INC. |
SEALAPEX |
08/15/1997 |
K010940 |
SYBRON DENTAL SPECIALTIES, INC. |
SEALAPEX 4 |
06/20/2001 |
K964174 |
TULSA DENTAL PRODUCTS, LTD. |
MINERAL TRIOXIDE AGGREGATE (MTA) |
02/10/1997 |
K162661 |
tYDS Biotech Incorporation |
SavDenTM MTA Root Canal Filling Materials |
04/25/2017 |
K971899 |
ULTRADENT PRODUCTS, INC. |
ENDO-SEAL |
06/26/1997 |
K042756 |
ULTRADENT PRODUCTS, INC. |
ENDOREZ |
10/26/2004 |
K992097 |
ULTRADENT PRODUCTS, INC. |
ENDOREZ |
10/26/1999 |
K071106 |
ULTRADENT PRODUCTS, INC. |
ENDOREZ OBTURATION KIT (WITH ACCELERATOR), MODEL 403, ENDOREZ ACCELERATOR (REFILL), MODEL 399 |
05/08/2007 |
K211905 |
Ultradent Products, Inc. |
UltraCal XS |
10/13/2021 |
K090992 |
VERICOM CO., LTD. |
WELL-PASTE |
04/21/2009 |
K080266 |
VERICOM CO., LTD. |
WELL-PEX |
02/06/2008 |
K170950 |
Vericom Co., Ltd. |
Well-Root ST |
12/20/2017 |
K963922 |
WALLACE A. ERICKSON & CO. |
ALPHA-DENT ROOT CANAL SEALER & FILLER |
12/06/1996 |