FDA.reportPublic FDA data

HyFlex™ EDM

Primary DI
E165600222850
Brand
HyFlex™ EDM
Company
Coltène/Whaledent GmbH + Co. KG
Model
60022285
Catalog number
60022285
Device description
HyFlex™ EDM Finishing File 60/0.02 21 mm
Published
2022-09-22
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
false

Contact Domains#

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
E165600222851PrimaryHIBCC0
E165600222850Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4973458050info.de@coltene.com
+4973458050service@coltene.com

Regulatory Flags#

DUNS number
315494443
Device count
3
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E1654610480ROEKO Aspirator tips4610484610482016-08-23
E1654620120ROEKO Surgitip-micro4620124620122016-08-23
E1654620130ROEKO Surgitip-micro4620134620132016-08-23
E1654620250ROEKO Surgitip4620254620252016-08-23
E1654620260ROEKO Surgitip4620264620262016-08-23
E1654620480ROEKO Surgitip4620484620482016-08-23
E1654620490ROEKO Surgitip4620494620492016-08-23
E1654630000ROEKO Double adapter4630004630002016-08-23
E1654630110ROEKO Adapter4630114630112016-08-23
E1654630250ROEKO Adapter4630254630252016-08-23
E165600182800ROEKO Surgitip-endo60018280600182802016-08-23
E165600191450ROEKO SurgitipSAMPLE EN600191452016-08-23
14260614073576HyFlex EDM60041081600410812025-10-22
14260614073583HyFlex EDM60041082600410822025-10-22
14260614073590HyFlex EDM60041083600410832025-10-22
14260614073606HyFlex EDM60041084600410842025-10-22
14260614073613HyFlex EDM60041085600410852025-10-22
14260614073620HyFlex EDM60041086600410862025-10-22
14260614073637HyFlex EDM60041087600410872025-10-22
14260614073644HyFlex EDM60041088600410882025-10-22

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