FDA.reportPublic FDA data

EdgeSeal Root Canal Sealer

Primary DI
D858EESEAL1230
Brand
EdgeSeal Root Canal Sealer
Company
EDGE ENDO LLC
Model
EESEAL
Device description
EdgeSeal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic proceduresand may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points).
Published
2017-01-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
D858EESEAL1230PrimaryHIBCC0

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). This GMDN code does not include gutta-percha. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight13.5Gram

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078474365
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818365021031EdgeTemp™ Plus Hydraulic Temporary Restorative MaterialETEMPPLUS2020-08-28
00818365020027EdgeTemp Hydraulic Temporary RestorativeEETEMP2017-01-25
D858EETEMP0LEdgeTemp Hydraulic Temporary RestorativeEETEMP2017-02-12
D858EETEMP1230EdgeTemp Hydraulic Temporary RestorativeEETEMP2017-02-11
10818365020994Edge™ EarLoop Procedure Masks572201757220172020-02-06
10818365021014Edge™ EarLoop Procedure Masks572201657220162020-02-06
10818365020932Edge™ EarLoop Procedure Masks”572200957220092020-02-06
10818365020949Edge™ EarLoop Procedure Masks572200857220082020-02-06
10818365020956Edge™ EarLoop Procedure Masks572200657220062020-02-06
10818365020963Edge™ EarLoop Procedure Masks572235257223522020-02-06
10818365020970Edge™ EarLoop Procedure Masks572201357220132020-02-06
10818365020987Edge™ EarLoop Procedure Masks572201157220112020-02-06
20818365020991Edge™ EarLoop Procedure Masks572201757220172020-02-06
10818365021007Edge™ EarLoop Procedure Masks572201557220152020-02-06
20818365021011Edge™ EarLoop Procedure Masks572201657220162020-02-06
00818365020096EdgeSurgicalTip™ #1AS3D12018-06-10
00818365020102EdgeSurgicalTip™ #2AS3D22018-06-10
00818365020119EdgeSurgical Tip™ #3P15LD2018-06-10
00818365020126EdgeSurgicalTip™ #4ASLD2018-06-10
00818365020133EdgeSurgicalTip™ #5P15RD2018-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518341511Any-PasteMEDICLUS CO.,LTDKIF2026-06-01
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