HyFlex EDM 60022278

GUDID E165600222780

HyFlex EDM Shaping Set Medium 20/0.05; 10/0.05; 25/~ 25 mm

Coltène/Whaledent GmbH + Co. KG

Rotary/reciprocating endodontic file/rasp, reusable

• Primary Device ID: E165600222780
• NIH Device Record Key: cd34631d-a44a-4c75-bf56-9c23bd0cc915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyFlex EDM
• Version Model Number: 60022278
• Catalog Number: 60022278
• Company DUNS: 315494443
• Company Name: Coltène/Whaledent GmbH + Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com
• Phone: +4973458050
• Email: service@coltene.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 37 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E165600222780 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

[E165600222780]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-02
• Device Publish Date: 2023-09-22

On-Brand Devices [HyFlex EDM]

• E165600234950: HyFlex EDM Shaping Set Max Curve 20/0.05; 15/0.03; 10/0.05 25 mm
• E165600234940: HyFlex EDM Shaping Set Max Curve 20/0.05; 15/0.03; 10/0.05 21 mm
• E165600234930: HyFlex EDM Glidepath File 15/0.03 21 mm
• E165600234920: HyFlex EDM Glidepath File 15/0.03 25 mm
• E165600222780: HyFlex EDM Shaping Set Medium 20/0.05; 10/0.05; 25/~ 25 mm
• E165600222770: HyFlex EDM Shaping Set Medium 20/0.05; 10/0.05; 25/~ 21 mm
• E165600222760: HyFlex EDM Preparation File 20/0.05 25 mm
• E165600222750: HyFlex EDM Preparation File 20/0.05 21 mm
• E165600222740: HyFlex EDM Finishing File 60/0.02 21 mm
• E165600222720: HyFlex EDM Finishing File 50/0.03 21 mm
• E165600222710: HyFlex EDM Finishing File 40/0.04 21 mm
• E165600222700: HyFlex EDM OneFile 25/~ 21 mm
• E165600222690: HyFlex EDM Glidepath File 10/0.05 21 mm
• E165600222680: HyFlex EDM Finishing Set 40/0.04; 50/0.03; 60/0.02 25 mm
• E165600222670: HyFlex EDM Shaping Set Simple 25/0.12; 10/0.05; 25/~ 21 mm
• E165600195990: HyFlex EDM Finishing File 60/0.02 25 mm
• E165600195980: HyFlex EDM Finishing File 50/0.03 25 mm
• E165600195970: HyFlex EDM Finishing File 40/0.04 25 mm
• E165600195960: HyFlex EDM Orifice Opener 25/0.12 15 mm
• E165600195950: HyFlex EDM OneFile 25/~ 25 mm
• E165600195940: HyFlex EDM Glidepath File 10/0.05 25 mm
• E165600193640: HyFlex EDM Finishing Set 40/0.04; 50/0.03; 60/0.02 25 mm
• E165600193630: HyFlex EDM Shaping Set Simple 25/0.12; 10/0.05; 25/~ 25 mm
• E165600361420: HyFlex EDM OGSF Sequence 18/0.11; 15/0.03; 18/0.045; 30/0.04 25 mm
• E165600361410: HyFlex EDM OGSF Sequence 18/0.11; 15/0.03; 18/0.045; 30/0.04 21 mm
• E165600361400: HyFlex EDM Orifice Opener 18/0.11 18 mm
• E165600361390: HyFlex EDM Finishing File 30/0.04 25 mm
• E165600361380: HyFlex EDM Finishing File 30/0.04 21 mm
• E165600361370: HyFlex EDM Shaping File 18/0.045 25 mm
• E165600361360: HyFlex EDM Shaping File 18/0.045 21 mm