FDA.reportPublic FDA data

ZenFlex RT

Primary DI
00195062161780
Brand
ZenFlex RT
Company
Kerr Corporation
Model
818-2703
Device description
25/.06/25 mm Retreatment File R4 NiTi File Refill Pack
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00195062161780PrimaryGS10
00195062160622Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195062161780001950621617801950621617800195062161780
00195062160622001950621606221950621606220195062160622

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
1-800-537-7123EndoRotaryCustCare@kerrdental.com

Regulatory Flags#

DUNS number
199354556
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195062160639ZenFlex RT818-27052026-10-13
00195062160646ZenFlex RT818-27002026-10-13
00195062161766ZenFlex RT818-27012026-10-13
00195062161773ZenFlex RT818-27022026-10-13
00195062162565Cement-ItN33A2026-07-29
00195062162572Cement-ItN33AB2026-07-29
00195062162589Cement-ItN33AC2026-07-29
00195062145582ZenFlex CM818-36022026-02-19
00195062145599ZenFlex CM818-36032026-02-19
00195062145605ZenFlex CM818-36042026-02-19
00195062145612ZenFlex CM818-36052026-02-19
00195062145629ZenFlex CM818-36062026-02-19
00195062145636ZenFlex CM818-36072026-02-19
00195062145643ZenFlex CM818-36082026-02-19
00195062145650ZenFlex CM818-36092026-02-19
00195062145667ZenFlex CM818-36102026-02-19
00195062145674ZenFlex CM818-36112026-02-19
00195062145681ZenFlex CM818-36122026-02-19
00195062145698ZenFlex CM818-36132026-02-19
00195062145704ZenFlex CM818-36142026-02-19

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
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
00810213812624EdgeEndoHSG-S Corp.EKS2026-06-24