FDA.reportPublic FDA data

Hygroscopic dental cement

Definition
A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.
GUDID devices
188
Last updated
2026-10-04 01:38:32

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08809518346677CanalPro CalciSealMEDICLUS CO.,LTD650032272026-09-22
00766054002963BIOSEALESSENTIAL DENTAL SYSTEMS, INC.1640-002026-09-21
08809518345106One-Fil Putty InjectableMEDICLUS CO.,LTD509-1 One-Fil Putty Injectable2026-05-21
00195062076381ZenSealKerr Corporation825-95012023-09-01
00304040016824Henry ScheinHENRY SCHEIN, INC.20203762016-09-24
00304040016848Henry ScheinHENRY SCHEIN, INC.20203592016-09-24
00810118106590Zarc by Avalon Biomed NeoSEALER EZFloNUSMILE, LTD.ZNSEZ22R2026-01-12
00810118106606Zarc by Avalon Biomed NeoSEALER EZFloNUSMILE, LTD.ZNSEZ22K2026-01-12
03701398102136Biodentine XP 200SEPTODONT SAS SPECIALITES SEPTODONT01C07102022-02-07
03701398102143Biodentine XP 500SEPTODONT SAS SPECIALITES SEPTODONT01C07202022-02-07
06972902583285C-RootBeijing C-Root Dental Medical Devices Co., LTD.1g2022-03-01
06972902583292C-RootBeijing C-Root Dental Medical Devices Co., LTD.1g2026-05-15
06972902583308C-RootBeijing C-Root Dental Medical Devices Co., LTD.0.5g2026-05-15
06972902583391C-RootBeijing C-Root Dental Medical Devices Co., LTD.2g2022-03-01
06976329180010Injectable Root Canal Bioceramic SealerEnpunuo Biotechnology Co., LtdNR SP-12024-06-21
06976329180027Injectable Root Canal Bioceramic SealerEnpunuo Biotechnology Co., LtdNR SP-32024-06-21
06976329180034Injectable Root Canal Bioceramic SealerEnpunuo Biotechnology Co., LtdNR SP-52024-06-21
06976329180041Injectable Root Canal Bioceramic SealerEnpunuo Biotechnology Co., LtdNR SP-0.52024-06-21
06976329180256Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180263Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180270Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180287Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180294Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180300Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180317Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180324Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180331Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180348Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180355Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
06976329180362Root canal repair materialsEnpunuo Biotechnology Co., LtdnRoot BP2025-10-31
07615208008654Apexit PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFT593991AN2022-08-22
07898078652961BIO-C REPAIR Angelus Industria de Produtos Odontologicos S ABIO-C REPAIR 1.5 g2026-03-25
08404535015126Brasseler USAPeter Brasseler Holdings, LLC5031795U02026-04-29
08809262954371VioSealSpident Co., Ltd.VioSeal2026-04-20
08809518341252One-FilMEDICLUS CO.,LTD508-1 One-Fil2026-05-11
08809518343706One-Fil PuttyMEDICLUS CO.,LTD509-2 One-Fil Putty2026-05-11
08809518346608CanalPro CalciSealMEDICLUS CO.,LTD600430332026-04-23
E22116461MTA vptVOCO GmbH16462025-10-14
00195062152771ZenSeal ProKerr Corporation825-95112026-02-10
00889989073140Tubli-SealORMCO CORPORATION003402016-09-08
00889989073157Tubli-SealORMCO CORPORATION010812016-09-08
00889989074116SealapexORMCO CORPORATION184322016-09-08
00889989074123SealapexORMCO CORPORATION185982016-09-08
00889989074130Pulp Canal Sealer EWTORMCO CORPORATION247452016-09-08
00889989074147Pulp Canal Sealer EWTORMCO CORPORATION247462016-09-08
00889989074154Pulp Canal SealerORMCO CORPORATION248732016-09-08
00889989074161Pulp Canal SealerORMCO CORPORATION248742016-09-08
00889989074178Pulp Canal SealerORMCO CORPORATION248752016-09-08
00889989074192Tubli-Seal EWTORMCO CORPORATION259032016-09-08
00889989074215Sealapex XpressORMCO CORPORATION336392016-09-08
00889989074222Tubli-Seal XpressORMCO CORPORATION336402016-09-08
00889989074239Tubli-Seal EWT XpressORMCO CORPORATION336412016-09-08
00810118105555Ultradent MTApex 5.0 g PowderNUSMILE, LTD.138692026-01-14
00810118105562Ultradent MTApex 5.0 ml GelNUSMILE, LTD.138682026-01-14
00850440008490Actacal Bioceramic SealerEngineered Endodontics, LLCACS2026-01-02
08800123819730Well-Root PTVERICOM CO., LTD.WT225-SE002025-11-27
08800123819747Well-Root PTVERICOM CO., LTD.WT202-KE002025-11-27
08800123819754Well-Root PTVERICOM CO., LTD.WT201-EE002025-11-27
08809254459402Well-Root PTVERICOM CO., LTD.WT225-S0002025-11-27
08809254459419Well-Root PTVERICOM CO., LTD.WT202-K0002025-11-27
00810118106576Avalon Biomed NeoSEALER EZFlo 2.2 g Refill SyringeNUSMILE, LTD.ANSEZRF2025-08-01
00810118106491Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex TipsNUSMILE, LTD.606201402025-07-15
00810118106507Avalon Biomed NeoSEALER Flo 2.2 g Kit with 20 Clear Flex TipsNUSMILE, LTD.ANSCF2025-07-15
00810118106514Avalon Biomed NeoSEALER EZFlo 2.2 g Kit with 20 Clear Flex TipsNUSMILE, LTD.ANSEZCF2025-07-15
00810118106552Avalon Biomed NeoSEALER Flo 0.5 g Kit with 4 Clear Flex TipsNUSMILE, LTD.ANSCFMK2025-07-15
00810118106569Avalon Biomed NeoSEALER EZFlo 0.5 g Kit with 4 Clear Flex TipsNUSMILE, LTD.ANSEZCFMK2025-07-15
E22116451MTA vptVOCO GmbH16452025-07-07
06976329180379Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdNR SP-0.52025-06-30
06976329180386Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdNR SP-12025-06-30
06976329180393Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdNR SP-22025-06-30
06976329180409Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdNR SP-32025-06-30
06976329180416Injectable Root Canal Bioceramic Sealer(nRoot SP)Enpunuo Biotechnology Co., LtdNR SP-52025-06-30
07898078659465PURE-Ca-SEAL Angelus Industria de Produtos Odontologicos S APURE-Ca-SEAL 0.5 g2025-03-20
00810118105593NeoSEALER EZFlo (0.5 g Syringe + 4 Tips) Mini KitNUSMILE, LTD.ANSEZFM2025-03-10
00810118105586Avalon Biomed NeoSEALER Flo 2.2 g syringe + 20 Basic Flex Tips KitNUSMILE, LTD.ANSBK2025-01-29
07898078659939Komet BioRepairAngelus Industria de Produtos Odontologicos S AKomet BioRepair 1.5 g2024-11-26
00766054002949BIOSEALESSENTIAL DENTAL SYSTEMS, INC.1640-002024-10-31
TQ26126092991Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.126092992024-10-31
08404535006025Brasseler USAPeter Brasseler Holdings, LLC5031639U02025-01-22
08404535006414Brasseler USAPeter Brasseler Holdings, LLC5031640U02025-01-22