FDA.reportPublic FDA data

EdgeEndo Sodium Hypochloite

Primary DI
00818365020034
Brand
EdgeEndo Sodium Hypochloite
Company
EDGE ENDO LLC
Model
EENAOCL
Device description
EdgeEndo sodium hypochlorite is a sodium hypochlorite solution in water with wetting agents to lower surface tension.
Published
2017-09-28
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
KJJCleanser, Root Canal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJJCleanser, Root CanalUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818365020034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818365020034008183650200348183650200340818365020034

GMDN Terms#

Term, Definition table
TermDefinition
Dental tooth-cleaning solutionA liquid or gel substance intended to be applied by a dental professional to clean tooth surfaces/cavities, often prior to or following a dental procedure (e.g., restoration, implantation). It typically contains appropriate cleaning agents and may be formulated to prevent plaque accumulation and gingivitis. It is often applied with a syringe, which may be included. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume480Milliliter

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
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10818207024944Endo Sealer Solvent SampleVista DentalKJJ2026-04-22
008101265062213D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCKJJ2026-03-24
00810118106415Avalon Biomed NeoSolvNUSMILE, LTD.KJJ2025-03-19
00810118106422Avalon Biomed NeoSolvNUSMILE, LTD.KJJ2025-03-19
08404535011982BC SealerPeter Brasseler Holdings, LLCKJJ2025-03-17
10818207024937EdgeUtopi BC Solvent Vista DentalKJJ2025-03-17
10810138823276RC MixEndo Direct LLCKJJ2025-03-03
D6620708377810Patterson®PATTERSON DENTAL SUPPLY, INC.KJJ2024-05-08
D6620708377990Patterson®PATTERSON DENTAL SUPPLY, INC.KJJ2024-05-08
00840326420324Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420348Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420362Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420386Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420331Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420355Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420379Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
00840326420393Young PerioDTYoung Innovations, Inc.KJJ2023-10-05
07630031730053Straumann PrefGelInstitut Straumann AGKJJ2023-09-30
10810138822668Endo Direct Sodium hypoclorite 3%Endo Direct LLCKJJ2023-07-15
10810138822675Endo Direct Sodium hypoclorite 6%Endo Direct LLCKJJ2023-07-15
10810138822682Endo Direct 17% EDTAEndo Direct LLCKJJ2023-07-15
00818365028870EdgeMix™US ENDODONTICS, LLCKJJ2023-06-25
00818365028979EdgeEndo®US ENDODONTICS, LLCKJJ2023-06-25
00818365029006EdgeEndo®US ENDODONTICS, LLCKJJ2023-06-25
10818207024340SmearOFF System (PS System)Vista DentalKJJ2023-06-09
10818207024357PS System - Chlor-Xtra Plus Bag (40mL)Vista DentalKJJ2023-06-09
10818207024401PS System - Chlor-Xtra Plus Bag (60mL)Vista DentalKJJ2023-06-09
10818207024418PS System - Chlor-Xtra Plus Bag (100mL)Vista DentalKJJ2023-06-09
00860004740322HYBENX Advanced Dental Debridement GelEpien Medical, Inc.KJJ2023-05-09