HyFlex EDM 60036141

GUDID E165600361410

HyFlex EDM OGSF Sequence 18/0.11; 15/0.03; 18/0.045; 30/0.04 21 mm

Coltène/Whaledent GmbH + Co. KG

Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable
Primary Device IDE165600361410
NIH Device Record Keyb50a4b16-3c3d-4fec-be04-e97bcf72127d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHyFlex EDM
Version Model Number60036141
Catalog Number60036141
Company DUNS315494443
Company NameColtène/Whaledent GmbH + Co. KG
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE165600361410 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


[E165600361410]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-22
Device Publish Date2024-02-14

On-Brand Devices [HyFlex EDM]

E165600234950HyFlex EDM Shaping Set Max Curve 20/0.05; 15/0.03; 10/0.05 25 mm
E165600234940HyFlex EDM Shaping Set Max Curve 20/0.05; 15/0.03; 10/0.05 21 mm
E165600234930HyFlex EDM Glidepath File 15/0.03 21 mm
E165600234920HyFlex EDM Glidepath File 15/0.03 25 mm
E165600222780HyFlex EDM Shaping Set Medium 20/0.05; 10/0.05; 25/~ 25 mm
E165600222770HyFlex EDM Shaping Set Medium 20/0.05; 10/0.05; 25/~ 21 mm
E165600222760HyFlex EDM Preparation File 20/0.05 25 mm
E165600222750HyFlex EDM Preparation File 20/0.05 21 mm
E165600222740HyFlex EDM Finishing File 60/0.02 21 mm
E165600222720HyFlex EDM Finishing File 50/0.03 21 mm
E165600222710HyFlex EDM Finishing File 40/0.04 21 mm
E165600222700HyFlex EDM OneFile 25/~ 21 mm
E165600222690HyFlex EDM Glidepath File 10/0.05 21 mm
E165600222680HyFlex EDM Finishing Set 40/0.04; 50/0.03; 60/0.02 25 mm
E165600222670HyFlex EDM Shaping Set Simple 25/0.12; 10/0.05; 25/~ 21 mm
E165600195990HyFlex EDM Finishing File 60/0.02 25 mm
E165600195980HyFlex EDM Finishing File 50/0.03 25 mm
E165600195970HyFlex EDM Finishing File 40/0.04 25 mm
E165600195960HyFlex EDM Orifice Opener 25/0.12 15 mm
E165600195950HyFlex EDM OneFile 25/~ 25 mm
E165600195940HyFlex EDM Glidepath File 10/0.05 25 mm
E165600193640HyFlex EDM Finishing Set 40/0.04; 50/0.03; 60/0.02 25 mm
E165600193630HyFlex EDM Shaping Set Simple 25/0.12; 10/0.05; 25/~ 25 mm
E165600361420HyFlex EDM OGSF Sequence 18/0.11; 15/0.03; 18/0.045; 30/0.04 25 mm
E165600361410HyFlex EDM OGSF Sequence 18/0.11; 15/0.03; 18/0.045; 30/0.04 21 mm
E165600361400HyFlex EDM Orifice Opener 18/0.11 18 mm
E165600361390HyFlex EDM Finishing File 30/0.04 25 mm
E165600361380HyFlex EDM Finishing File 30/0.04 21 mm
E165600361370HyFlex EDM Shaping File 18/0.045 25 mm
E165600361360HyFlex EDM Shaping File 18/0.045 21 mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.