FDA.report

Easy Bassi

Primary DI
07908626201739
Brand
Easy Bassi
Company
EASY EQUIPAMENTOS ODONTOLOGICOS LTDA.
Model
RFG40013106
Device description
ROOTFLEX GLIDEPATH 40/.01 31MM (PACK OF 6)
Published
2025-07-14
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

Related Records

Product Codes

CodeName
EKSFile, Pulp Canal, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07908626201739PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
910611768
Device count
1
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
true
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 DIBrandModelCatalogPublished
07908626202972Easy BassiBRKIT1RPLUS25BL2025-09-09
07908626202989Easy BassiBRRPLUS150425BL42025-09-09
07908626202996Easy BassiBRRPLUS250825BL42025-09-09
07908626203009Easy BassiBRS2KITG25BL2025-09-09
07908626203016Easy BassiBRS2KITR25BL2025-09-09
07908626203023Easy BassiBRS2KITY25BL2025-09-09
07908626203030Easy BassiBRRT200621BL2025-09-09
07908626203047Easy BassiBRRT200625BL2025-09-09
07908626203054Easy BassiBRRT250821BL2025-09-09
07908626203061Easy BassiBRRT250825BL2025-09-09
07908626203078Easy BassiBRRT301021BL2025-09-09
07908626203085Easy BassiBRRT301025BL2025-09-09
07908626203092Easy BassiBRRTKIT21BL2025-09-09
07908626203108Easy BassiBRRTKIT25BL2025-09-09
07908626203115Easy BassiBRR350521BL42025-09-09
07908626203122Easy BassiBRR350525BL42025-09-09
07908626203139Easy BassiBRR250621BL42025-09-09
07908626203146Easy BassiBRR250625BL42025-09-09
07908626203269Easy BassiBRKIT1XTAPER25BL2025-09-09
07908626202415Easy BassiBRLOGIC250321BL42025-08-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
80810213810008EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810015EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810022EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810039EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810046EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810053EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810060EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810077EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810084EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810091EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810107EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810114EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810121EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810138EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810145EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810152EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810169EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810176EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810183EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810190EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810206EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810213EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810220EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810237EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810244EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810251EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810268EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810275EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810282EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810299EdgeEndoHSG-S Corp.EKS2026-03-23