FDA.report

Edge File

Primary DI
10810047642005
Brand
Edge File
Company
US ENDODONTICS, LLC
Model
SX70425MM
Catalog number
SX70425MM
Device description
Sterile Endodontic Rotary Files
Published
2023-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EKSFILE, PULP CANAL, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810047642008PrimaryGS10
10810047642005Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810047642008008100476420088100476420080810047642008
1081004764200510810047642005

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
Radiation Sterilization

Contacts

PhoneEmail
+1(423)283-0047Bobby.bennett@us-endo.com

Regulatory Flags

DUNS number
061317427
Device count
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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

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10810047645358EdgeSequel UtopiaES150421SEES150421SE2023-07-28
10810047645365EdgeSequel UtopiaES150425SEES150425SE2023-07-28
10810047645372EdgeSequel UtopiaES150431SEES150431SE2023-07-28
10810047645389EdgeSequel UtopiaES250421SEES250421SE2023-07-28
10810047645396EdgeSequel UtopiaES250425SEES250425SE2023-07-28
10810047645402EdgeSequel UtopiaES250431SEES250431SE2023-07-28
10810047645419EdgeSequel UtopiaES300421SEES300421SE2023-07-28
10810047645426EdgeSequel UtopiaES300425SEES300425SE2023-07-28
10810047645433EdgeSequel UtopiaES300431SEES300431SE2023-07-28
10810047645440EdgeSequel UtopiaES400421SEES400421SE2023-07-28
10810047645457EdgeSequel UtopiaES400425SEES400425SE2023-07-28
10810047645464EdgeSequel UtopiaES400431SEES400431SE2023-07-28
10810047645471EdgeSequel UtopiaES500421SEES500421SE2023-07-28
10810047645488EdgeSequel UtopiaES500425SEES500425SE2023-07-28
10810047645495EdgeSequel UtopiaES500431SEES500431SE2023-07-28
10810047645501EdgeSequel UtopiaES250621SEES250621SE2023-07-28
10810047645518EdgeSequel UtopiaES250625SEES250625SE2023-07-28
10810047645525EdgeSequel UtopiaES250631SEES250631SE2023-07-28
10810047645532EdgeSequel UtopiaES300621SEES300621SE2023-07-28
10810047645549EdgeSequel UtopiaES300625SEES300625SE2023-07-28

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