FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919807285
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5026554U0
Device description
17% EDTA
Published
2023-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
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
00887919807285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919807285008879198072858879198072850887919807285

GMDN Terms#

Term, Definition table
TermDefinition
Dental root surface conditionerA dental material, typically of neutral pH, used for topical application on exposed/scaled root surfaces for the removal of the smear layer (adherent debris produced when cutting the enamel or dentin in cavity or endodontic preparation, Circa 1 micron thick) during dental/periodontal surgery. The material is removed (washed off) after the recommended period to expose the collagenous matrix of dentine surfaces. It is typically presented in the form of a gel and consists of, e.g., edetate disodium (EDTA) and carboxymethylcellulose (CMC) with a neutral pH. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919581727DENTFLEX FIBER POST5013918L05013918L02026-09-25
00887919581741DENTFLEX FIBER POST5013919L05013919L02026-09-25
00887919581765DENTFLEX FIBER POST5013920L05013920L02026-09-25
08404535030334Brasseler USA5032038U05032038U02026-09-25
08404535030365Brasseler USA5032039U05032039U02026-09-25
08404535030396Brasseler USA5032040U05032040U02026-09-25
08404535030426Brasseler USA5032041U05032041U02026-09-25
08404535030433Brasseler USA5032042U05032042U02026-09-25
08404535030464Brasseler USA5032043U05032043U02026-09-25
08404535030488Brasseler USA5032044U05032044U02026-09-25
08404535030518Brasseler USA5032045U05032045U02026-09-25
08404535030549Brasseler USA5032046U05032046U02026-09-25
08404535030570Brasseler USA5032047U05032047U02026-09-25
08404535030600Brasseler USA5032048U05032048U02026-09-25
08404535030631Brasseler USA5032049U05032049U02026-09-25
08404535030662Brasseler USA5032050U05032050U02026-09-25
00887919673866Brasseler USA5022561U05022561U02023-01-25
00887919676201Brasseler USA5022789U05022789U02023-01-25
00887919749981Brasseler USA5025306U05025306U02023-01-25
00887919752301Brasseler USA5025362U05025362U02023-01-25

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