FDA.reportPublic FDA data

Komet BioRepair

Primary DI
07898078659939
Brand
Komet BioRepair
Company
Angelus Industria de Produtos Odontologicos S A
Model
Komet BioRepair 1.5 g
Catalog number
BCR2
Device description
Bioceramic reparative material ready-to-use.
Published
2024-11-26
Public version status
Update
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
07898078659939PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898078659939078980786599397898078659939

GMDN Terms#

Term, Definition table
TermDefinition
Hygroscopic dental cementA 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
906943303
Device count
1
Lot or batch
true
Manufacturing date on label
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
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
07898078654996EdgeUtopia Repair Material EdgeUtopia Repair Material 0.25 g386302024-10-14

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
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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
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