HyFlex™ EDM 60019633
GUDID E165600196330
HyFlex™ EDM Finishing File 60/0.02 25 mm
Coltène/Whaledent GmbH + Co. KG
Rotary/reciprocating endodontic file/rasp, reusable| Primary Device ID | E165600196330 |
| NIH Device Record Key | 4e599358-8a29-4bc0-a0b1-9c8de3402fb8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HyFlex™ EDM |
| Version Model Number | 60019633 |
| Catalog Number | 60019633 |
| Company DUNS | 315494443 |
| Company Name | Coltène/Whaledent GmbH + Co. KG |
| Device Count | 3 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com | |
| Phone | +4973458050 |
| info.de@coltene.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E165600196330 [Unit of Use] |
| HIBCC | E165600196331 [Primary] |
FDA Product Code
| EKS | File, Pulp Canal, Endodontic |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
[E165600196330]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-30 |
| Device Publish Date | 2022-09-22 |
On-Brand Devices [HyFlex™ EDM]
| E165600235760 | HyFlex™ EDM Shaping Set Max Curve 20/0.05; 15/0.03; 10/0.05 21 mm |
| E165600235750 | HyFlex™ EDM Shaping Set Max Curve 20/0.05; 15/0.03; 10/0.05 25 mm |
| E165600235740 | HyFlex™ EDM Glidepath File 15/0.03 21 mm |
| E165600235730 | HyFlex™ EDM Glidepath File 15/0.03 25 mm |
| E165600222890 | HyFlex™ EDM Shaping Set Medium 20/0.05; 10/0.05; 25/~ 25 mm |
| E165600222880 | HyFlex™ EDM Shaping Set Medium 20/0.05; 10/0.05; 25/~ 21 mm |
| E165600222870 | HyFlex™ EDM Preparation File 20/0.05 21 mm |
| E165600222860 | HyFlex™ EDM Preparation File 20/0.05 25 mm |
| E165600222850 | HyFlex™ EDM Finishing File 60/0.02 21 mm |
| E165600222840 | HyFlex™ EDM Finishing File 50/0.03 21 mm |
| E165600222830 | HyFlex™ EDM Finishing File 40/0.04 21 mm |
| E165600222820 | HyFlex™ EDM OneFile 25/~ 21 mm |
| E165600222810 | HyFlex™ EDM Glidepath File 10/0.05 21 mm |
| E165600222800 | HyFlex™ EDM Finishing Set 40/0.04; 50/0.03; 60/0.02 25 mm |
| E165600222790 | HyFlex™ EDM Shaping Set Simple 25/0.12; 10/0.05; 25/~ 21 mm |
| E165600196420 | HyFlex™ EDM Finishing Set 40/0.04; 50/0.03; 60/0.02 25 mm |
| E165600196410 | HyFlex™ EDM Shaping Set Simple 25/0.12; 10/0.05; 25/~ 25 mm |
| E165600196330 | HyFlex™ EDM Finishing File 60/0.02 25 mm |
| E165600196320 | HyFlex™ EDM Finishing File 50/0.03 25 mm |
| E165600196310 | HyFlex™ EDM Finishing File 40/0.04 25 mm |
| E165600196300 | HyFlex™ EDM Orifice Opener 25/0.12 15 mm |
| E165600196290 | HyFlex™ EDM OneFile 25/~ 25 mm |
| E165600196280 | HyFlex™ EDM Glidepath File 10/0.05 25 mm |
Trademark Results [HyFlex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYFLEX 98852873 not registered Live/Pending |
ROYAL GRAND USA, LLC 2024-11-14 |
 HYFLEX 88672617 not registered Live/Pending |
FNA GROUP, INC. 2019-10-29 |
 HYFLEX 86763954 not registered Dead/Abandoned |
OneSubsea IP UK Limited 2015-09-22 |
 HYFLEX 85785009 4534375 Live/Registered |
Ansell Limited 2012-11-21 |
 HYFLEX 79387383 not registered Live/Pending |
Hitachi Energy Holdings AG 2023-11-09 |
 HYFLEX 79268367 not registered Live/Pending |
Suzhou Tuntex Fiber & Carpet Co.,Ltd. 2019-06-26 |
 HYFLEX 79259135 not registered Live/Pending |
Clariant AG 2019-03-13 |
 HYFLEX 79152564 not registered Dead/Abandoned |
OSSTEMIMPLANT CO., LTD. 2014-07-23 |
 HYFLEX 76227590 2665541 Dead/Cancelled |
P GROUP S.r.l. 2001-03-16 |
 HYFLEX 75255792 2309590 Live/Registered |
ANSELL LIMITED 1997-03-11 |
 HYFLEX 75105995 2049152 Dead/Cancelled |
Krupp Polysius A.G. 1996-05-17 |
 HYFLEX 74517214 1953704 Live/Registered |
NEENAH NORTHEAST, LLC 1994-04-26 |
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