FDA.reportPublic FDA data

Edge X7 Utopia

Primary DI
07640142445296
Brand
Edge X7 Utopia
Company
FKG Dentaire Sàrl
Model
X7UAsst0421SE
Catalog number
X7UAsst0421SE
Device description
Edge X7 Utopia Assortment .04/21mm
Published
2023-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07640142445296PrimaryGS10
07640142444053Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142445296076401424452967640142445296
07640142444053076401424440537640142444053

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640452461030EdgeGlidepathEGP0221HTS4EGP0221HTS42026-06-03
07640452461047EdgeGlidepathEGP0225HTSEGP0225HTS2026-06-03
07640452461054EdgeGlidepathEGP0231HTSEGP0231HTS2026-06-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877830090EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
06941877830106EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
06941877830113EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
07640452461030EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461047EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461054EdgeGlidepathFKG 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