| Primary Device ID | E165600361420 |
| NIH Device Record Key | 8e9f8b15-9e57-4ebd-8022-25e7b444732c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HyFlex EDM |
| Version Model Number | 60036142 |
| Catalog Number | 60036142 |
| 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 |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com | |
| Phone | +4973458050 |
| service@coltene.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E165600361420 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
[E165600361420]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-22 |
| Device Publish Date | 2024-02-14 |
| 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 |