FDA.reportPublic FDA data

3% NaOCL Sodium Hypochlorite

Primary DI
10818207020397
Brand
3% NaOCL Sodium Hypochlorite
Company
Vista Dental
Model
317018
Device description
For the debridement and irrigation of root canals during and after instrumentation. 16 ounce bottle.
Published
2018-08-06
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082470000SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRAInter-Med, Inc.2009-04-03KJJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818207020397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081820702039710818207020397

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036623932
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
10818207025170Fluorescent In Office Whitening Kit5042902026-07-20
00850194007763Zr-P Bottle905772026-06-04
00818207020840ZrP Syringe Kit905782021-01-29
10818207024920Endo Sealer Solvent3170332026-04-22
10818207024944Endo Sealer Solvent Sample317033-M2026-04-22
00850194007862Desensify12019-12-13
00850194007893Omni Etch Ceramic Etch and Silane12019-12-13
10818207024937EdgeUtopi BC Solvent 108182070249372025-03-17
10818207025071Endocator Starter Kit4077302025-11-07
10818207025088Endocator Swabs (20pk)4077312025-11-07
10818207025064ReminGelRGEL30002025-10-09
10818207020205Vista-Cal Standard Kit5026002018-07-31
10818207020878Velvet Etch 5033152021-05-13
30818207020872Velvet Etch 5033002021-05-13
00850194007787Purify+ Gel 5 Pack12019-12-13
00850194007794Purify+ Liquid 5 Pack12019-12-13
00850194007954Purify+ Gel Single Pack12019-12-13
00850194007961Purify+ Liquid Single Pack12019-12-13
20818207020202Vista-Cal Refill Kit5026012018-07-31
00850194007466RE-GEN Cleanser1907192016-06-16

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