FDA.reportPublic FDA data

HENRY SCHEIN

Primary DI
00304040065457
Brand
HENRY SCHEIN
Company
HENRY SCHEIN, INC.
Model
5700794
Catalog number
5700794
Device description
EDTA 17% Solution w/ Luer Cap
Published
2018-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00304040065457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040065457003040400654573040400654570304040065457

GMDN Terms#

Term, Definition table
TermDefinition
Root canal cleaning solutionA fluid or gel material intended to be used in dentistry to facilitate cleaning/irrigation of the root canal during/after endodontic instrumentation to remove the smear layer, pulpal tissue, necrotic materials, and bacteria from the root canal, before placement of the endodontic filling; it may also act as a lubricant to facilitate the passage of an instrument (e.g., file/rasp) into the root canal. It is typically available as a disinfecting solution (e.g., chlorhexidine, sodium hypochlorite solution) delivered into the canal with an irrigation needle, or similar device, providing mechanical and possibly chemical cleaning of the canal. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
Premarket exempt
true
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
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818207024920Endo Sealer SolventVista DentalKJJ2026-04-22
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