FDA.reportPublic FDA data

ZenFlex CM

Primary DI
00195062145599
Brand
ZenFlex CM
Company
Kerr Corporation
Model
818-3603
Device description
.13/.06/31mm ZenFlex CM NiTi FILE REFILL PACK
Published
2026-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKSFile, Pulp Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195062145599PrimaryGS10
00195062145254Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195062145599001950621455991950621455990195062145599
00195062145254001950621452541950621452540195062145254

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, single-useA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-537-7123kerrcustcare@kavokerr.com

Regulatory Flags#

DUNS number
199354556
Device count
6
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10814978021267Build-It FRN32FA2016-08-01
10814978021281Build-It FRN32FB2016-08-01
10814978021298Build-It FRN32FC2016-08-01
10814978021304Build-It FRN32FD2016-08-01
10814978021311Build-It FRN32FE2016-08-01
10814978023230Build-It FRN322016-08-01
00814978021185Build-It FRN32AA2016-08-01
00814978021192Build-It FRN32AB2016-08-01
00814978021208Build-It FRN32AC2016-08-01
00814978021215Build-It FRN32AD2016-08-01
00814978021222Build-It FRN32AE2016-08-01
00814978021321Build-It FRN32FS2016-08-01
00814978021338Build-It FRN32FSA2016-08-01
00814978021345Build-It FRN32FSB2016-08-01
00814978021352Build-It FRN32FSC2016-08-01
00814978021369Build-It FRN32FSD2016-08-01
00814978021437Cement-It Universal C&BN33A2016-08-01
00814978021444Cement-It Universal C&BN33AB2016-08-01
00814978021451Cement-It Universal C&BN33AC2016-08-01
00814978022588BreezeN97E2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195062160639ZenFlex RTKerr CorporationEKS2026-10-13
00195062160646ZenFlex RTKerr CorporationEKS2026-10-13
00195062161766ZenFlex RTKerr CorporationEKS2026-10-13
00195062161773ZenFlex RTKerr CorporationEKS2026-10-13
00195062161780ZenFlex RTKerr CorporationEKS2026-10-13
00850085821171K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821188K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821195K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821201H FilesCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00810213812419EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812426EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812433EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812440EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812457EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812464EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812471EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812488EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812495EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812501EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812518EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812525EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812532EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812549EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812556EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812563EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812570EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812587EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812594EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812600EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812617EdgeEndoHSG-S Corp.EKS2026-06-24