FDA.reportPublic FDA data

MTA-FILLAPEX

Primary DI
07898078658277
Brand
MTA-FILLAPEX
Company
Angelus Industria de Produtos Odontologicos S A
Model
MTA-Fillapex 4g
Catalog number
827
Device description
Bioceramic Root Canal Sealer - MTA-Fillapex 4gMTA-Fillapex is a bioceramic root canal sealer based on MTA (mineral trioxide aggregate). Its composition provides long term sealing capacity, high radiopacity, promotes the stimulation of hard tissue formation in the dental apex and perforation sites, low expansion during setting, low solubility in contact with tissue fluids, excellent viscosity for insertion, does not stain the tooth, it is a eugenol-free material and has appropriate working time for endodontic procedures.
Published
2019-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIFResin, Root Canal Filling

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIFResin, Root Canal FillingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898078658277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898078658277078980786582777898078658277

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic filling/sealing materialA prefabricated, solid dental substance used in endodontics to fill or permanently obturate the root canal of a tooth. The substance may set without assistance of moisture, and is typically intended for orthograde use (i.e., a root filling placed from the coronal aspect). The device has various metallic or polymeric compositions that include (but are not limited to) silver (Ag), methylmethacrylate, zinc oxide eugenol, glass alkenoate, and calcium hydroxide (Ca(OH)2). It does not include gutta-percha. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
+554321013200sac@angelus.ind.br

Regulatory Flags#

DUNS number
906943303
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898078652961BIO-C REPAIR BIO-C REPAIR 1.5 g38812026-03-25
07898078659939Komet BioRepairKomet BioRepair 1.5 gBCR22024-11-26
07898078652701Komet BioRepairKomet BioRepair 0.5 gBCR12024-10-14
07898078650134SPEED GUNSPEED GUN 1 unit81812025-03-20
07898078657423SPEED GUNSPEED GUN Kit81802025-03-20
07898078659427EdgeUtopia RRM Dispensing GunEdgeUtopia RRM Dispensing Gun - 1 unit380602025-03-20
07898078659465PURE-Ca-SEAL PURE-Ca-SEAL 0.5 g39712025-03-20
07898078659236PERMA MESHPERMA MESH 1 unit44292025-02-17
07898078659243E-FIBERE-FIBER 10 cm 1.6 mm44302025-02-17
07898078659267E-FIBERE-FIBER 5 cm 1.6 mm44312025-02-17
07898078659274E-FIBERE-FIBER 10 cm 1.2 mm44322025-02-17
07898078659281E-FIBERE-FIBER 5 cm 1.2 mm44332025-02-17
07898078659298E-FIBERE-FIBER 10 cm 1.4 mm44342025-02-17
07898078659403E-FIBERE-FIBER 5 cm 1.4 mm44352025-02-17
07898078656228MTA REPAIR HPMTA REPAIR HP 0.17 g8432020-11-09
07898078656648MTA REPAIR HPMTA REPAIR HP 0.425 g8462020-11-09
07898078658864BIO-C REPAIRBIO-C REPAIR 2 g38632020-11-05
07898078659823BIO-C SEALER ION+ BIO-C SEALER ION+ 2 g38432020-11-09
07898078659847BIO-C REPAIRBIO-C REPAIR 0.5 g38612020-11-05
07898078651605PURE-Ca-SEALPURE-Ca-SEAL 2 g39702024-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518345106One-Fil Putty InjectableMEDICLUS CO.,LTDKIF2026-05-21
06972902583292C-RootBeijing C-Root Dental Medical Devices Co., LTD.KIF2026-05-15
06972902583308C-RootBeijing C-Root Dental Medical Devices Co., LTD.KIF2026-05-15
08809518341252One-FilMEDICLUS CO.,LTDKIF2026-05-11
08809518343706One-Fil PuttyMEDICLUS CO.,LTDKIF2026-05-11
08404535015126Brasseler USAPeter Brasseler Holdings, LLCKIF2026-04-29
08809518346608CanalPro CalciSealMEDICLUS CO.,LTDKIF2026-04-23
08809262954371VioSealSpident Co., Ltd.KIF2026-04-20
07898078652961BIO-C REPAIR Angelus Industria de Produtos Odontologicos S AKIF2026-03-25
07290115050523BJM Root Canal SealerB.J.M. LABORATORIES LTDKIF2026-03-20
00195062152771ZenSeal ProKerr CorporationKIF2026-02-10
00850440008490Actacal Bioceramic SealerEngineered Endodontics, LLCKIF2026-01-02
08800123819730Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08800123819747Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08800123819754Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08809254459402Well-Root PTVERICOM CO., LTD.KIF2025-11-27
08809254459419Well-Root PTVERICOM CO., LTD.KIF2025-11-27
06976329180256Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180263Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180270Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180287Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180294Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180300Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180317Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180324Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180331Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180348Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180355Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
06976329180362Root canal repair materialsEnpunuo Biotechnology Co., LtdKIF2025-10-31
E22116461MTA vptVOCO GmbHKIF2025-10-14