FDA.reportPublic FDA data

EdgeGlidepath

Primary DI
07640452461054
Brand
EdgeGlidepath
Company
FKG Dentaire Sàrl
Model
EGP0231HTS
Catalog number
EGP0231HTS
Device description
EdgeGlidepath, Size 16, 31mm EdgeTaper Platinum, Size F2, 21mm
Published
2026-06-03
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
07640452461054PrimaryGS10
07640452464307Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640452461054076404524610547640452461054
07640452464307076404524643077640452464307

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
4
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
07640452461030EdgeGlidepathEGP0221HTS4EGP0221HTS42026-06-03
07640452461047EdgeGlidepathEGP0225HTSEGP0225HTS2026-06-03
07640452461061EdgeOne FireEOF21ASSTEOF21ASST2026-06-03
07640452461078EdgeOne FireEOF25ASSTEOF25ASST2026-06-03
07640452461085EdgeOne FireEOF31ASSTEOF31ASST2026-06-03
07640452461092EdgeOne FireEOF21ASSTDEOF21ASSTD2026-06-03
07640452461108EdgeOne FireEOF25ASSTDEOF25ASSTD2026-06-03
07640452461115EdgeOne FireEOF31ASSTDEOF31ASSTD2026-06-03
07640452461122EdgeOne FireEOFLG21HTSEOFLG21HTS2026-06-03
07640452461139EdgeOne FireEOFLG25HTSEOFLG25HTS2026-06-03
07640452461146EdgeOne FireEOFLG31HTSEOFLG31HTS2026-06-03
07640452461153EdgeOne FireEOFMED21HTSEOFMED21HTS2026-06-03
07640452461160EdgeOne FireEOFMED25HTSEOFMED25HTS2026-06-03
07640452461177EdgeOne FireEOFMED31HTSEOFMED31HTS2026-06-03
07640452461184EdgeOne FireEOFPRI21HTSEOFPRI21HTS2026-06-03
07640452461191EdgeOne FireEOFPRI25HTSEOFPRI25HTS2026-06-03
07640452461207EdgeOne FireEOFPRI31HTSEOFPRI31HTS2026-06-03
07640452461214EdgeOne FireEOFSM21HTSEOFSM21HTS2026-06-03
07640452461221EdgeOne FireEOFSM25HTSEOFSM25HTS2026-06-03
07640452461238EdgeOne FireEOFSM31HTSEOFSM31HTS2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640452461030EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461047EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461061EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461078EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461085EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461092EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461108EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461115EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461122EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461139EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461146EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461153EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461160EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461177EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461184EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461191EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461207EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461214EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461221EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461238EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461245EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461252EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461269EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452462235EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462242EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462259EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462266EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462273EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462280EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462297EdgeTaperFKG Dentaire SàrlEKS2026-06-03