FDA.reportPublic FDA data

Edge Evolve

Primary DI
07640452460491
Brand
Edge Evolve
Company
FKG Dentaire Sàrl
Model
EE250821HTX
Catalog number
EE250821HTX
Device description
EdgeEvolve, Size 25.08, 21mm
Published
2026-10-27
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

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
07640452460491PrimaryGS10
07640452464611Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640452460491076404524604917640452460491
07640452464611076404524646117640452464611

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.

Regulatory Flags#

DUNS number
482884061
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640452460194Edge EvolveEE170421HTXEE170421HTX2026-10-27
07640452460200Edge EvolveEE170425HTXEE170425HTX2026-10-27
07640452460217Edge EvolveEE170429HTXEE170429HTX2026-10-27
07640452460224Edge EvolveEE170621HTXEE170621HTX2026-10-27
07640452460231Edge EvolveEE170625HTXEE170625HTX2026-10-27
07640452460248Edge EvolveEE170629HTXEE170629HTX2026-10-27
07640452460255Edge EvolveEE170821HTXEE170821HTX2026-10-27
07640452460262Edge EvolveEE170825HTXEE170825HTX2026-10-27
07640452460279Edge EvolveEE170829HTXEE170829HTX2026-10-27
07640452460286Edge EvolveEE171021HTXEE171021HTX2026-10-27
07640452460293Edge EvolveEE171025HTXEE171025HTX2026-10-27
07640452460309Edge EvolveEE171029HTXEE171029HTX2026-10-27
07640452460316Edge EvolveEE200421HTXEE200421HTX2026-10-27
07640452460323Edge EvolveEE200425HTXEE200425HTX2026-10-27
07640452460330Edge EvolveEE200429HTXEE200429HTX2026-10-27
07640452460347Edge EvolveEE200621HTXEE200621HTX2026-10-27
07640452460354Edge EvolveEE200625HTXEE200625HTX2026-10-27
07640452460361Edge EvolveEE200629HTXEE200629HTX2026-10-27
07640452460378Edge EvolveEE200821HTXEE200821HTX2026-10-27
07640452460385Edge EvolveEE200825HTXEE200825HTX2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640452460194Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460200Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460217Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460224Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460231Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460248Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460255Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460262Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460279Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460286Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460293Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460309Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460316Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460323Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460330Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460347Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460354Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460361Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460378Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460385Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460392Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460408Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460415Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460422Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460439Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460446Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460453Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460460Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460477Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460484Edge EvolveFKG Dentaire SàrlEKS2026-10-27