FDA.reportPublic FDA data

Verge

Primary DI
D915K21061
Brand
Verge
Company
Plastcare USA
Model
K2106
Device description
Stainless Steel K File Size 6 Length 21
Published
2020-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
D915K21062PackageHIBCC10In Commercial Distribution
D915K21061PrimaryHIBCC0
D915K21060Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, reusableA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. 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 an endodontic reamer. This is a reusable device.

Regulatory Flags#

DUNS number
079299604
Device count
6
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D915MBK21SentinelMBK22019-12-12
D915MBL21SentinelMBL22019-12-12
D915MPI21SentinelMPI22019-12-12
D915MWH21SentinelMWH22019-12-12
D915WHW1PlastcareWHW2020-05-01
D915WHW2PlastcareWHW2020-05-01
D915MBK22SentinelMBK22019-12-12
D915MBL22SentinelMBL22019-12-12
D915MPI22SentinelMPI22019-12-12
D915MWH22SentinelMWH22019-12-12
D915RIT50101PlastcareRIT-50102020-03-11
D915RIT50151PlastcareRIT-50152020-03-11
D915RIT50201PlastcareRIT-50202020-03-11
D915RIT50251PlastcareRIT-50252020-03-11
D915RIT50152PlastcareRIT-50152020-03-11
D915RIT50202PlastcareRIT-50202020-03-11
D915RIT50252PlastcareRIT-50252020-03-11
D915RIT50102PlastcareRIT-50102020-03-11
D915CLB1PlastcareCLB2020-03-10
D915CLB2PlastcareCLB2020-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810213812631EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812648EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812655EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812662EdgeEndoHSG-S Corp.EKS2026-06-24